Characteristics of clinical study reports, protocols, and publicly available data sources

Trial No used in our studyOriginal Trial IDDate of protocolDates of protocol amendmentsDate first patient enrolledDate CSR approvedAppendices missing from CSRDate of single trial journal articleApproval date of Lilly trial registry reportNo of pages
CSRsJournal articleLilly trial registry report
1HMAQa20 Oct ’984 Feb ’9911 Feb ’992 Oct ’01Yes*Mar ’021716 Nov ’04951731
2HMAQb20 Oct ’984 Feb ’9910 Mar ’992 Oct ’01Yes*No publication16 Nov ’04859NA26
3HMATa16 Dec ’99None10 Mar ’0017 Sep ’01Yes*No publication16 Nov ’041221NA24
4HMATb16 Dec ’99None9 Mar ’0017 Sep ’01Yes*Aug ’041816 Nov ’0411961123
5HMAYa15 Feb ’0030 Mar ’0016 Nov ’0015 Jan ’03Yes†20041923 Jun ’0522111471
6HMAYb15 Feb ’0030 Mar ’0031 Oct ’0015 Jan ’03Yes‡May ’062027 Jul ’0620951233
7HMBHa19 Jul ’00None09 Nov ’0027 Jul ’01Yes†Apr ’022115 Nov ’04916820
8HMBHb19 Jul ’00None13 Nov ’006 Aug ’01Yes*20022223 Nov ’04911821
9HMBC25 Sep ’013 Oct ’01, 20 Dec ’01, 27 Feb ’02, 12 Jun ’02§11 Mar ’0223 Sep ’03Yes*Perahia,25¶ Fava,23**Hudson24††17 Jul ’063369Perahia25 8; Fava23 9, Hudson24 1150

CSR=clinical study report; NA=not applicable.

*Sample case report forms; list of investigators (names and addresses provided but additional pages missing); ethics review board documents; listing of patients receiving treatment from specific batches; audit certificates; documentation of laboratory methods; additional statistical methods; individual patient listings other than adverse events.

†All appendices listed in * and additionally appendix of errors to locked database.

‡All appendices listed in * with exception of listing of patients receiving treatment from specific batches, and documentation of laboratory methods.

§Additional telephone call to patients from one investigative site.

¶Reported on continuation (randomised) phase, and additionally on some adverse events in open label duloxetine lead-in phase, and in follow up phase.

**Reported on data from rescue phase only.

††Reported on open label duloxetine lead-in phase only.