The independent RIAT team reanalyzed the same 275-participant trial using the protocol, clinical study report, appendices, individual-participant data, and case report forms. It found no efficacy on prespecified outcomes and increased harms; its acute-and-taper approach counted suicidal or self-injurious behavior in 11 paroxetine, four imipramine, and two placebo participants.
Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs.
The independent RIAT team reanalyzed the same 275-participant trial using the protocol, clinical study report, appendices, individual-participant data, and case report forms. It found no efficacy on prespecified outcomes and increased harms; its acute-and-taper approach counted suicidal or self-injurious behavior in 11 paroxetine, four imipramine, and two placebo participants. GSK and original authors disputed the critique; GSK said the original article reflected the investigators’ honestly held views. This is a reanalysis, not a new randomized trial or a retraction.