Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Antidepressants in children and adolescents
- Andrew Herxheimer (3 January 2004)
-
Prescribing trends of antidepressants in children and adolescents
- Macey L Murray, Corinne S de Vries and Ian CK Wong (5 January 2004)
-
SSRIs in Children
- Mark Abramowicz, MD (7 January 2004)
-
More debate on the concept of childhood depression needed
- Sami Timimi (7 January 2004)
-
Caution needed for tricyclic prescribing in depressed adolescents
- Bernadka W Dubicka, Richard Harrington, Professor of Child Psychiatry, email:Richard.harrington (7 January 2004)
-
Fish oil in depression
- Edmond V O`Flaherty (8 January 2004)
-
Fish oil
- Lisa C Blakemore-Brown (8 January 2004)
-
Treatment of major depressive disorder in children and adolescents: even more caution should be considered.
- Federico Marchetti, Marzia Lazzerini, Egidio Barbi (9 January 2004)
-
Will Depressed Adolescents Lose Out?
- Kenneth D Shenderey (9 January 2004)
-
TWO MORE LESSONS TO BE LEARNT
- Robert M Wrate (19 January 2004)
-
A suicide is a process
- Sergio A. Pérez Barrero (23 January 2004)
-
Clarity or obfuscation in antidepressant trials?
- Hans A de Haan, Anthony W Fox, David A Shapiro (7 February 2004)
-
SSRIs in Young People
- Gillian Baird, Professor Eric Taylor (16 February 2004)
|
|
|||
|
Andrew Herxheimer, emeritus fellow, UK Cochrane Centre London N3 2NL UK
Send response to journal:
|
Ramchandrani's editorial focuses entirely on the use of selective serotonin reuptake inhibitors (SSRIs) in the treatment of 'major depressive disorder', just as did the CSM chairman's statement on which he comments. Did he not think it odd that the statement said nothing about obsessive-compulsive disorder (OCD), panic disorder, social phobia, or general anxiety disorder, for which various SSRIs are also prescribed? The CSM does not say whether the use of SSRIs for these conditions in people under 18 is justified and appropriate. Presumably the CSM's expert working group is considering these questions, but that requires a clear official statement now. The British National Formulary (BNF Sept 2003, p193-7] notes the following indications - CITALOPRAM: panic disorder CHILD not recommended (adolescent not mentioned) ESCITALOPRAM: CHILD & ADOLESCENT under 18 not recommended [strange, since it is virtually identical with citalopram] FLUOXETINE: bulaemia, OCD, CHILD not recommended (adolescent not mentioned) FLUVOXAMINE: OCD, indicated for children over 8 PAROXETINE: OCD, panic disorder, social phobia, gen anxiety disorder, CHILD not recommended (adolescent not mentioned) SERTRALINE: OCD, indicated for children over 6 and adolescents; post- traumatic stress disorder, CHILD not recommended (adolescent not mentioned) VENLAFAXINE: general anxiety disorder, CHILD & ADOLESCENT under 18 not recommended It may be too late for the CSM/MHRA to unravel this confusion in time for the March edition of the BNF, but that makes it especially urgent for them to issue a clear statement that will help prescribers, and patients and their parents. Competing interests: None declared |
|||
|
|
|||
|
Macey L Murray, Research fellow Centre for Paediatric Pharmacy Research, School of Pharmacy, University of London, WC1N 1AX, Corinne S de Vries and Ian CK Wong
Send response to journal:
|
Editor-The recommended withdrawal of the use of selective serotonin reuptake inhibitors (SSRIs) in children, announced by the Medicines and Healthcare products Regulatory Agency (MHRA)(1,2), has prompted us to report our preliminary findings on the prescribing trends of antidepressants (ATDs) in children and adolescents in general practice. We are involved in a project called CHAPTER (Child and Adolescence Psychotropic medication Therapy Evaluation Research), which evaluates the safety and use of psychotropic medications in children and adolescents. We are particularly interested in patterns of tricyclic antidepressants (TCAs) and SSRI use, as their efficacy in paediatric depressive disorders has been questioned. Our data come from the General Practice Research Database(3), which covers approximately 5% of the UK population. We carried out a study of ATDs utilisation between 1 January 1992 and 31 December 2001. We found 23,999 children and adolescents were prescribed at least one ATD, and the total number of ATD prescriptions issued was 88,522. Fifty- nine percent of prescriptions were for TCAs, 40% were for SSRIs. The most commonly prescribed ATDs were imipramine (25% of prescriptions), fluoxetine (19%), and amitriptyline (18%). Paroxetine, sertraline, citalopram, venlafaxine, and fluvoxamine made up 21% of all ATD prescriptions issued. Sixty-three, 35 and 2 percent of patients were given TCAs, SSRIs, and other ATDs respectively as the first ATD prescribed. Less than 0.1% of patients received an MAOI. In patients aged 10 years and less, the most commonly recorded indication for TCAs use was enuresis (78%), whereas in those aged 15+ years it was depression (53%). In this older age group, ATDs use was three times more common in girls than boys. Drug choice favoured TCAs in 1992 when they were prescribed to nine times more patients than SSRIs, whereas by 2001, twice as many patients were prescribed SSRIs than TCAs. Our findings show that SSRIs had gained popularity for the treatment of depression compared with TCAs, but TCAs were still being used commonly in the treatment of nocturnal enuresis. These trends may change following the MHRA recommendation. However, TCAs are not useful in treating depression in pre-pubertal children, and there is only marginal evidence to support the use of TCAs in adolescents(4). This may leave us in a situation where few effective pharmacological treatments are available, so there is an urgent need to research more effective and safer medicines for children and adolescents with depression. Children deserve equal rights with adults in receiving evidence-based treatment(5). Macey L Murray Corinne S de Vries, Senior lecturer, Department of Pharmacoepidemiology, Postgraduate Medical School, University of Surrey, Guildford GU2 7DJ Ian C K Wong, Director and reader, Centre for Paediatric Pharmacy Research, School of Pharmacy, University of London and Institute of Child Health, University College London Acknowledgments: IW's post is funded by Department of Health Public Health Career Scientist Award 1. http://bmj.bmjjournals.com/uknews/news20031210.shtml (accessed 10/12/2003) 2. http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/ssrioverview_101203.htm (accessed 12/12/2003) 3. Walley T, Mangani A. The UK General Practice Research Database. BMJ 1997;350:1097-9. 4. Hazell P, O'Connell D, Heathcote D, Henry D. Tricyclic drugs for depression in children and adolescents. Cochrane Database Syst Rev. 2002;(2):CD002317 5. Wong ICK, Camilleri-Novak D, Stephens P. Rise in psychotropic drug prescribing in children in the UK - An urgent public health issue. Drug Safety 2003;26(15):1117-8. Competing interests: IW has received funding from various pharmaceutical companies including companies that produce SSRIs but none were related to this study. MM and CdV have no competing interests to declare. |
|||
|
|
|||
|
Mark Abramowicz, MD, Editor The Medical Letter, 1000 Main St, New Rochelle, NY 10801, USA
Send response to journal:
|
From across the ocean it seems curious that you are accepting the recommendations of your Committee on Safety of Medicines without asking to see the data on the risk of suicide in children. What has surfaced so far is not very impressive (see The Medical Letter, volume 45, page 53, July 7, 2003). Competing interests: None declared |
|||
|
|
|||
|
Sami Timimi, consultant child and adolescent psychiatrist Ash Villa, Willoughby Road, Sleaford NG34 8QA
Send response to journal:
|
Paul Ramchandani's editorial is a timely and welcome review of the recent emerging evidence concerning antidepressants in children and adolescents and raises serious questions about the impact of the profit motive on our ability to access impartial evidence. It also raises serious questions on the very nature of the conceptual system we use in child psychiatry as it is the idea of 'childhood depression' (once considerred very rare) that is the gateway diagnosis that has allowed the pharmaceutical industry the tools it needed to mass market its products (which are, as the editorial shows, of dubious effectiveness and with potentially serious side effects that have been down-played). Childhood depression has slipped into child psychiatric nosology and along with other dubious diagnoses (such as ADHD) has contributed to a continuing invasion of context-stripped bio-medical perspectives into child psychiatric theory and practice, with the inevitable result that drugs, with a poor safety profile and of dubious efficacy, are routinely over-prescribed. Not only is this likely to cause unecessary harm to children at the physical level (side-effects) but also at a socio-cultural level as we increasingly ascribe a whole host of complex difficulties that children, their families, their schools and their local communities experience to a highly hypothetical, abstract and unsubstantiated idea that these problems are caused by some unidentified chemical processes in an individual child's brain. The poor scientific basis to medicalized child psychiatry's claims about the existance of a discrete disorder called 'depression' in childhood is then a big part of the reason we are only just waking up to what the drug industry has been doing. What we need to prevent further repitition of this scenario (as is already happening at a far bigger and potentially more damaging scale in the ADHD industry) is more than a more robust system, requiring full disclosure of information from drug companies (and god knows this is urgently neded too). Our profession needs an urgent open and honest debate about our nosology and the validity of a diagnostic system that has led to a worrying increase in the innapropriate medicalization of childhood problems (Timimi, 2002). Timimi, S. (2002) Pathological Child Psychiatry and the Medicalization of Childhood. Hove: Brunner-Routledge. Competing interests: None declared |
|||
|
|
|||
|
Bernadka W Dubicka, honorary clinical research fellow in child psychiatry Royal Manchester Children's Hospital M27 4HA, Richard Harrington, Professor of Child Psychiatry, email:Richard.harrington
Send response to journal:
|
EDITOR-We would like to raise a number of points in response to Dr Ramchandani’s editorial on the treatment of depression in children and adolescents, following the recent Committee on Safety of Medicines guidance (1). Whilst we agree with the views of Dr Ramchandani, we are concerned at the possibility that tricyclic antidepressants may now be considered as a second line choice of pharmacological treatment in depressed adolescents. Although a recent Cochrane meta-analysis of tricyclic antidepressants has shown some evidence that these drugs may be effective in adolescence, the authors concluded that the evidence is marginal and the effect size is likely to be moderate at best (2). With regards to using tricyclics as a second line treatment, they note that the one trial that used tricyclics in this context demonstrated no treatment benefit (3). In addition, as Dr Ramchandani points out, tricyclics have an adverse side effect profile, and are associated with mortality in overdose. A longitudinal study, which followed 159 depressed children and adolescents into adulthood, found that of 7 subjects who committed suicide, 3 died from fatal tricyclic overdoses (4). In their epidemiological study, Meltzer et al (5) found that, on the basis of parent and child reports, 41% of depressed 11-15 year olds had tried to harm themselves and therefore access to tricyclic antidepressants may significantly increase the risk of fatal overdose. On this basis, we do not believe that the benefits outweigh the risks of using tricyclic antidepressants in this age group and therefore they cannot be recommended as a second line treatment in adolescent depression. 1 Ramchandani P. Treatment of major depressive disorder in children and adolescents. BMJ 2004; 328: 3-4. (3 January). 2 Hazell P, O’Connell D, Heathcote D, Henry D. Tricyclic drugs for depression in children and adolescents. Cochrane Database Syst Rev 2003; (4):CD002317. 3 Birmaher B, Waterman GS, Ryan ND, Perel J, McNabb J, Balach L, Beaudry MB, Nasr FN, Karambelkar J, Elterich G, Quintana H, Wiliamson DE, Rao U. Randomised controlled trial of amitriptyline versus placebo for adolescents with ‘treatment-resistant' major depression. Journal of the American Academy of Child and Adolescent Psychiatry 1998; 37: 527-35. 4 Rao U, Weissman MM, Martin JA & Hammond RW. Childhood depression and risk of suicide: preliminary report of a longitudinal study. Journal of the American Academy of Child and Adolescent Psychiatry 1993; 32: 21-27. 5 Meltzer H, Harrington R, Goodman R, Jenkins R. Children and adolescents who try to harm, hurt or kill themselves. London: Stationary Office, 2001. Competing interests: Both authors are involved in a fluoxetine treatment study of adolescent depression funded by the National Health Service Research and Development National Coordinating Centre for Health Technology Assessment. |
|||
|
|
|||
|
Edmond V O`Flaherty, G.P. Gleneagle,Greygates,Mount Merrion,Co. Dublin
Send response to journal:
|
Depression seems to be related to a low level of fish intake.Dr Joseph Hibbeln in a one page contribution including a graph to The Lancet ("Fish consumption and major depression" in Volume 351,issue 9110 page 1213) shows that fish consumption in different countries has a high negative correlation with depression(r=-0.84,p<0.005).May I suggest that as well as using medication that omega-3 fish oil should routinely be added to the diet of those who are depressed.Indeed I am of the opinion that most people should take fish oil and have set up a website at www.omega3.20megsfree.com to show where it might be useful. Competing interests: None declared |
|||
|
|
|||
|
Lisa C Blakemore-Brown, Psychologist UK
Send response to journal:
|
This is interesting. I decided to use fish oil capsules when I had breast cancer and during radiotherapy and chemotherapy treatment. I'd read something about it being used to reduce the chances of sunburn. The oncologist commented on the extent of the burns in the former treatment, as these were less than he would have expected and was interested when I mentioned the fish oil. Competing interests: None declared |
|||
|
|
|||
|
Federico Marchetti, Clinical Paediatricians Clinica Pediatrica, IRCCS Burlo Garofolo, via dell'Istria 65/1, 34100- Trieste, Italy, Marzia Lazzerini, Egidio Barbi
Send response to journal:
|
EDITOR- The increase in recent years of psychotropic prescriptions for children and adolescents has generated a considerable controversy in the medical literature and popular press. In his excellent editorial, Ramchandani properly calls for caution in the use of selective serotonin reuptake inhibitors (SSRI) in children and adolescents (1). We think that an even major attention should be posed on the efficacy and safety of treatment in major depressive disorders (MDD) in this population. The results of randomised controlled trials show that about 50% of children and adolescents with MDD improve with placebo, and that the difference in the improvement of symptoms with SSRI is no bigger than 10%(2). These findings suggest that children may be more responsive than adults to nonspecific measures of support that are included in the placebo response, possibly because children and adolescents are in a more dependent and reactive developmental state (3). As Ramchandani correctly points out psychological treatments, including cognitive behaviour therapy, have been used extensively, and several randomised trials attest to its efficacy in mild or moderately severe depression (2). Little evidence exists to support their use in young people with more severe depression, which could receive a significant benefits from pharmacological treatments. Nevertheless there are no available results at all in the medical literature on the efficacy of different treatments of MDD in terms of long term outcomes as social and occupational functioning, quality of life, rate of recurrence (2). Actually we don't know if the striking increase of prescription of SSRI documented in some medical setting is secondary to a longer length of treatments, to changes in the severity and recurrence of medical disorders, or to an improvement in the access to psychiatric care (4). As a matter of fact there is no clear cut evidence that any of the former causes may be relevant, and possibly the increase of prescription of SSRI may just be due to a therapeutic attitude based on an insufficient cost-benefits analysis. Actually in other medical settings, as for example in Italy, the use of antidepressant drugs in children and adolescents is still much lower (5). The next step and challenge of health service research should be to consider the effects of psychotropic prescription practice on utilization of services, medical and mental health expenditures and long term outcomes for children and their families. If changes in practice patterns and drugs use are not found to be associated with variations in quality of care and patients outcomes, interventions should be defined to address the inappropriate use of pharmacological treatments. Reference 1. Ramchandani P. Treatment of major depressive disorder in children and adolescents. BMJ 2004;328:3-4; 2. Hazell P. Depression in children and adolescents. Clin Evid 2002;8:330- 9; 3. Varley CK. Psychopharmacological treatment of major depressive disorder in children and adolescents. JAMA 2003;290;1091-3; 4. Rushton JL, Whitmire T. Pediatric stimulant and selective serotonin reuptake inhibitor prescription trends. Arch Pediatr Adolesc Med 2001;155:560-65; 5. Marchetti F, Lazzerini M. Uso degli antidepressivi in età pediatrica. Prospettive in Pediatria 2003;33:185-94 Competing interests: None declared |
|||
|
|
|||
|
Kenneth D Shenderey, Senior Partner in General Practice Leeds LS14 6DX
Send response to journal:
|
The conclusion of the CSM is based on 2 premises, 1) Lack of effectiveness 2) Increased risk of suicide. None of the evidence stacks up. Even the FDA paper (http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01256.html) points out that there is likely to be no difference in effectiveness between Sertraline and Fluoxetine. Further it states quite clearly that in all the organised trials, no completed suicide was reported. It also quite correctly points out that in Major Depressive Disease, suicide is a likely event anyway. (In any case, the correct management of depressed children involves suicide watch). If there is to be an increase in risk, it is likely to only be at the beginning of therapy when the disinhibiting effects of SSRIs are not yet balanced by improving mood patterns. What I find most unsatisfactory is the failure to publish the data on which the conclusions are based. The FDA concludes that the trials to show effectiveness were possibly flawed and inconclusive. This is an example of bandwaggoning on media scare stories and its likeliest effect is to increase morbidity and suicide risk in that age group. Competing interests: None declared |
|||
|
|
|||
|
Robert M Wrate, Honorary Fellow Department of Psychiatry, University of Edinburgh, Royal Edinburgh Hospital EH10 5HF
Send response to journal:
|
DEVELOPING A SHARED VIEW OF RISK FURTHER LESSONS FROM THE CONTROVERSY ABOUT SSRIs FOR CHILD AND ADOLESCENT DEPRESSION EDITOR – Ramchandani has produced a useful review of the background to, and details of, the CSM’s recent changes to SSRI prescribing for young people 1 (Editorial 3/01/2004), but in spelling out the lessons to be learnt he does not go far enough. At least two other important lessons are present. First, on how such announcements should be conveyed to, and by, the media. Professor Duff’s announcement 2 was quickly followed by a Guardian report (11/12/2003) suggesting that the CSM review had “only set up at the end of last year because of mounting public pressure”. Richard Brook, the chief executive of Mind (Britain’s foremost mental health charity), was reported to assert that “the loud voices of users and a high profile campaign started a course of events that led to (the MDRA) announcement”, presumably remembering too last year’s BBC Panorama programme on paroxetine. The Times headline “Most antidepressants too high-risk for children” (11/12/2003) was similar to that in the Daily Mail. In The Independent (10/12/2003) the headline “Threat of suicide leads to ban of major antidepressants for children” was followed in the body of the article by the statement that paroxetine “was banned after research showed it could trigger suicidal thoughts and thoughts of self-harm”. A later Guardian article, headlined “Drugs for depressed children banned” (12/2003), included the statement “because of evidence, suppressed for years, report that they can cause young people to become suicidal”, where in the drug trials a “worrying increase” had been observed compared with placebo. In all these media stories, three main themes are apparent : when prescribing for children, doctors have been too complacent about the risks involved; many antidepressants can trigger suicidality; and these drugs are now banned. The last of these is fallacious : the new licensing restrictions only applied to prescribing within primary care. Continued specialist prescribing of all the ‘banned’ compounds remains possible, but this particular misrepresentation is likely to endorse a public belief about professional complacency. In consequence, much increased parental objections to specialist prescribing drugs for depression may occur, perhaps little different to those many GPs already face when recommending MMR vaccination. A non-blaming reflection of the MMR and SSRI debates between health agencies and health correspondents is urgently required to assist the media exercise their responsibilities to the better mutual advantage of the public and their own organisations; newspapers’ concern for ‘breaking news’ should not outweigh their other duties. The second lesson has yet to be fully learnt by some of the medical profession. The BMJ Editorial indicated that drug trial data drawn from cohort studies numbering hundreds (summarised in www.mhra.gov.uk) will influence prescribing practice for patient populations of tens of thousands. In these drug trials, the treatment effect-size for most SSRIs was extremely small, and respondents quite often reported physical side- effects so, with the exception of fluoxetine, the balance of risks and benefits was considered “unfavourable”. Media coverage conflated this conclusion with their concern about the alleged adverse psychological sequalae of antidepressants (e.g. 4/378 patients treated with paroxetine had reported suicidal thoughts compared with only 7/285 on placebo). In fact, the CSM’s Working Party’s Level 2 review of a study of sertraline, a difference of less than three individuals would have wiped out the observed risk for suicidality altogether. Health correspondents demonstrated little understanding of the statistical power necessary to reach significant conclusions, but their alarmist response also reflects an ill-thought MDRA position, which appears not to have recognised that the overall observed rates for suicidal ideation in these drug trials were far too low. Clinical epidemiological data on adolescent depression indicates that many normal adolescents experience suicidal thoughts 3, including the majority of untreated depressed adolescents eg 4. The representativeness of the drug trial cohorts or the validity of their measures must be in serious doubt. Teenage depression is often associated with co-morbid disorders (e.g. substance abuse); such subjects, as well perhaps as many with moderately severe symptoms or suicidal thoughts, may very well have not been entered into most of the eleven drug trials reviewed. There is no evidence that the CSM was concerned about this. Why not ? Most doctors would agree that stopping antidepressants because some depressed adolescents may later volunteer information about suicidal thoughts would be as wrong-headed as arguing that certain cancer treatments should be discontinued because some cancer patients later die. The public’s perception of treatment ‘risk’ may be best examined as a social construct, but untreated depression presents major health risks, including for suicide 5. Community-based studies of adolescent depression indicate a very low rate of inception of identified cases into treatment 4. The substantial efforts now being made to improve the recognition of adolescent depression (e.g. www.depressioninteenagers.co.uk ) need to be supported by properly thought-through treatment initiatives and well- considered public statements about treatment choices. Dr RM Wrate
conflict of interest : none 1. Ramchandani P. Treatment of major depressive disorder in children and adolescents (Editorial). BMJ 2004; 328 : 3-4. 2. Committee on Safetyof Medicines. Use of selective serotonin reuptake inhibitors (SSRIs) in children and adolescents with major depressive disorder (MDD).www.mhra.gov.uk/(accessed 18 Dec 03). 3. Pfeffer CR, Lipkins R, Plutchik R et a. Normal children at risk for suicidal behaviour : a two-year follow-up study. Journal of the American Academy of Child and Adolescent Psychiatry 1998; 27 : 34-41. 4. Goodyer I and Cooper PJ. A community study of depression in adolescent girls. II. The clinical features of identified disorder. British Journal of Psychiatry 1993: 163 : 374-378. 5. Coyle JT, Pine DS, Charney DS et al. Depression and bipolar support alliance consensus statement on the unmet needs in diagnosis and treatment of mood disorders in children and adolescents. Journal of the American Academy of Child and Adolescent Psychiatry 2003; 42 : 1494-1503. Competing interests: None declared |
|||
|
|
|||
|
Sergio A. Pérez Barrero, WPA'Suicidology Section Founder Dpto de Psiquiatria Hosp.
Send response to journal:
|
Suicide is a process, not a puntual act. In childhood, as it is a logical thing to suppose, the suicide risk factors must be mainly detected in the family context. Generally the emotional family climax is chaotic, because of its members behavior: the roles and limits of its members, are not respected. The parents, when they live together, are constantly quarrelling and sometimes there is physical violence between them, addressing the most vulnerable members: the young people,(the boys and girls), and the oldest, elder people, as well. Frequently the parents may be suffering a mental disease, the father an alcoholic man, or the mother a depressive woman. The father’s alcoholism is also suffered by the rest of the family, as this disease involves all the members; may it be because of the disorders in his behavior, his violence, the suicide acts, his economic problems, or his inability to keep to the roles assigned to the person, that the others have to assume. The mother depression, apart from the suicide danger meant in itself, becomes a pessimism, a hopelessness, the sensation of loneliness and lack of motivation. It may be added to that the ill-treatment situation, when the mother can’t achieve under this condition to satisfy the emotional needs of the care of the boy and girl. Another suicide risk factor of importance in childhood, is the suicide behavior of any of the parents. Although it hasn’t been demonstrated that the suicide is genetically determined, it is a fact that the suicide may be imitated above all by the younger generations under the name of the Werther Effect, due to the suicide committed among the young people who had read Goethe’s novel, “The sorrow of young Werther”, whose leading character ends his life shooting himself. Sometimes this process is not completely conscious and the suicide is carried out as a mechanism of identification, a process that adds to the personality some feature or behavior of the subject he had identified with. In other occasions, the genetic disposition is transmitted not to commit suicide but to some illnesses where these symptoms are frequent. Among these diseases the depression and the schizophrenia is found in any of its clinic forms. Both have been described as one the main suicide risk in the adolescence. Parent-child relationships may become a risk suicide factor when they are streaked by ill-treatment situations, and sexual abuse, physical or psychological. The violence against children, in any of its ways, is one of the factors that hampers the spiritual development of their personality, creating some features in it that leads to carry out suicide acts. Among them we can see their own violence, their impulses, their low self-esteem, how difficult it is for them to relate themselves with persons who mean a lot to them, their mistrust; these are only a few. Sometimes a characteristic oh this relationship is overprotection, permissiveness, and lack of authority , which conspire against the good development of boys’ or girls’ personality, who become stubborn, demanding, none tolerant to frustrations, manipulative and egocentric, pretending that all human beings would treat them in the same tolerant way as their relatives would do, which arises several problems from their earliest childhood, that becomes harder in their adolescence, when socializing takes a very important part in the definite growth of the personality. Obviously, a child suicide crisis arises out of the relation of the boy or girl with their family environment, and it is manifested by some signs in their behavior. They become either aggressive or passive in their behavior at home or at school , show changes in their habits in their meals or in their sleep; they could be very angry, or the opposite. And as regards to their habits of sleep, they could keep awake, with insomnia,having night terrors, in which they wake up with their eyes wide open, afraid, sweating, complaining of what they have seen, and is the cause of the anguish they are feeling. They may also suffer nightmares or bad dreams, as well as enuresis, urinating the bed-cover while they are sleeping. In other occasions,they may show an excessive sleepiness, that may be a symptom of depression in these ages. Rebelliousness without any apparent reason , not to participate in their habitual games with other children or friends, to give away their valuable possessions, and to write farewell notes, are signs that may be also observed during a suicidal youth crisis. Finally, what is the evidence that SSRI's is the cause of suicide in children and adolescent?.Depression is a cause of suicide and SSRI's are used in that condition. Competing interests: None declared |
|||
|
|
|||
|
Hans A de Haan, Pharmaceutical Physician Consultant, San Diego, CA, USA, Anthony W Fox, David A Shapiro
Send response to journal:
|
Dr Ramchandani’s editorial (1) highlights several conundrums that clinicians are struggling to resolve following the recent CSM guidance on the hazards of prescribing SSRIs to young people with depressive disorders. Clearly, this remains a significant clinical problem with no simple therapeutic solutions. Unfortunately, this editorial offers little constructive advice for the practicing physician and complicates the situation by adding additional misunderstandings and unsubstantiated allegations of misconduct. The data on the relative benefits of pharmacotherapy in children and adolescents with depression are clearly difficult to assess. However, an important part of the context is that antidepressant trials are difficult to conduct, and that well-recognized therapies often fail to show efficacy under clinical trial conditions, even in adults (2, 3). As the Medicines and Healthcare products Regulatory Agency (MHRA) makes clear on its website, only two of the SSRIs are approved in children, in each case for obsessive compulsive disorder, not depression (4). Dr. Ramchandani calls for additional research in this area (an eminently reasonable position), while also insinuating the largest trials with fluoxetine are unreliable simply because they were funded by the drug manufacturer. It is worth noting that there are numerous regulations relating to the quality and conduct of such trials. Further, Dr. Ramchandani, and the BMJ by publishing the editorial, appear to allege that irregularities have occurred as “data from trials about serious adverse effects of some antidepressant drugs, held by the pharmaceutical companies concerned, seem not to have been previously released to the Committee on Safety of Medicines”. This is a serious allegation and, since there are clear and specific regulations regarding the prompt reporting of serious adverse experiences to the regulatory authorities, implies that he is aware of such irregularities. If so, we would remind him of his responsibility to share his evidence with the appropriate regulatory authorities. He could also consider bringing it to the attention of colleagues that are committed to quality of clinical research and pharmacovigilance, both within and without the pharmaceutical industry (5,6). If he and the Journal are not aware of such irregularities, we would suggest that the text in the editorial is revised appropriately. Lastly, Dr Ramchandani declares no competing interests as the author. We therefore infer that he has neither consulted for companies developing or marketing psychotropic drugs, nor participated in clinical trials involving these drugs. It may be argued that a physician more involved in such research may have been able to clarify the implications of the research and regulatory status to aid the practicing physician. Hans de Haan MBBS FRCS PhD FFPM Anthony W. Fox BSc FFPM MD(Lond) DipPharmMedRCP CBiol FIBiol FRSA David A. Shapiro MBBCh MRCP FFPM San Diego, CA, USA hadehaan@aol.com (1) Treatment of major depressive disorder in children and adolescents: Most selective serotonin reuptake inhibitors are no longer recommended BMJ 2004; 328: 3 – 4. (January 3) (2) Ross DC, Quitkin FM, Klein DF. A typological model for estimation of drug and placebo effects in depression. J Clin Psychopharmacol 2002; 22: 414-418. (3) Moncrieff, J. Are antidepressants overrated? A review of methodological problems in antidepressant trials. J Nerv Ment Dis 2001, 288-295. (4) http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/ssrioverview_101203.htm#summary accessed Feb 21. 2004 (5) Code of Ethics for Pharmaceutical Physicians. www.aapp.org. (6) History and Aims of the Faculty. www.fpm.org.uk Competing interests: None declared |
|||
|
|
|||
|
Gillian Baird, consultant Paediatrician Guy's Hospital SE1 9RT, Professor Eric Taylor
Send response to journal:
|
To the Editor of the British Medical Journal SSRIS in young people Ramchandani (2) commented in an Editorial on the advice from the Committee on Safety of Medicines (1) which contraindicates SSRIs other than fluoxetine for major depressive disorder in children and gives general advice for SSRI prescribing. He notes that the dramatic announcement and clear directive has created difficulties for prescribing doctors who have children currently treated with SSRIs other than fluoxetine and also raised concerns about the basis for the advice when most of the trial data reviewed by the CSM are not otherwise published and have been hard to evaluate – for instance, to know to whom the trial results should generalise. The conclusion of lack of efficacy might not apply to the small minority of affected children who show a severe adult- type depression. We are writing on behalf of a multidisciplinary group of prescribers, both paediatricians and child and adolescent psychiatrists, that recently discussed the advice and evidence on the CSM website, and found a unanimous consensus on several points. 1. The contra-indication applies only to children treated for major depressive disorder. Some prescribers are withholding SSRIs altogether and that would be a disservice to children with other indications (notably, obsessive-compulsive disorder) - for whom there was no evidence of increase in suicidal thoughts. 2. There is a pressing need for better research evaluation of SSRIs – as for other drugs that are unlicensed yet often used and authoritatively recommended. Trials should be published even if results are negative, and a framework should be found to encourage paediatric trials. A full analysis of the data submitted to CSM should be published. 3. There is a clear need for further trials adequately powered and comparing treatments, medication and psychological (eg CBT) in children. Good practice in mental health services would normally be to suggest psychological measures first. This cannot, however, be universal. There is a serious shortage of practitioners competent to give effective interventions such as cognitive-behavioural therapy or interpersonal therapy. Some very severely depressed young people will need medication urgently. 4. The first choice of medication in major depressive disorder is ordinarily fluoxetine. There may well be circumstances, however, in which a responsible clinician should use other antidepressant drugs – eg for those refractory to fluoxetine, or for whom it is contraindicated, or for those already successfully treated with another SSRI. 5. If an SSRI other than fluoxetine is to be used, caution is necessary. We thought it should be a Consultant-only decision, informed consent should be obtained from the child if old enough, or the parent if not, and the indications should be justified in writing in the notes and signed by the Consultant. Written information (such as the CSM leaflet) should be given to parents, and children if able to understand. Continuing treatment should be supervised by a child psychiatrist or suitably trained paediatrician. In summary, we wish to emphasise the existence of a body of experienced clinical opinion that accepts the data so far released but calls for more; that considers the contraindication to SSRIs to be relative, not absolute; and that proposes safeguards when treatment with a “contraindicated” SSRI is the best option for an individual child. Yours faithfully Gillian Baird FRCPCH (secretary) Eric Taylor FRCPsych (chair) For the Paediatric Psychopharmacology Group Refs: 1. www.mhra.gov.uk Committee on Safety of Medicines. Use of selective serotonin reuptake inhibitors (SSRIs) in children and adolescents with major depressive disorder (MDD). 2. Paul Ramchandani, Treatment of major depressive disorder in children and adolescents Most selective serotonin reuptake inhibitors are no longer recommended BMJ 2004;328:3-4 (3 January) Competing interests: None declared |
|||