Study 329 had an 8-week acute phase and a further 24 week continuation phase. After 8 weeks the participants had an option to enter a further continuation phase. The idea was to see how ongoing treatment shaped up. The continuation phase was never published. Never even talked about.
After publication of the acute phase rewrite in September 2015, the same team began work on the continuation phase. They always expected to publish this in the International Journal of Risk and Safety in Medicine, but it seemed like a good idea to send it to the Journal of the American Association for Child and Adolescent Psychiatry (JAACAP) first, as the original Keller paper was published in JAACAP.
The former editor Mina Dulcan and the current editor Andres Martin and the American Association of Child and Adolescent Psychiatry, whose journal this is, have been lobbied heavily from 2006 onwards by Leemon McHenry and Jon Jureidini, trying to get them to do the decent thing and retract the Keller paper. But in vain. It seemed pretty certain they would refuse the continuation phase, but they needed to be given the opportunity to dig a deeper hole. And they did.
Why was this study important?
- Longer term (6 month) studies of antidepressants, like this one, are vanishingly rare.
- This disproves claims you need to keep taking an antidepressant for 6 months or more to prevent relapse.
- This study shows the taper/withdrawal phase has, on one way of analyzing the data, the highest rates of suicidal events.
- GSK didn’t publish their version of this continuation phase of the study.
- JAACAP refused to publish this version of it.
The study was published on 21 September 2016. The full text is available here – along with the reviews from the Journal of the American Association for Child and Adolescent Psychiatry (JAACAP) available here.