Background : This study was conducted to investigate the role of natural course of a major depressive
episode in short-term, placebo-controlled studies.
Methods : We analyzed for sustained response all placebo arms and tricyclic arms from all
randomized three-arm studies that were conducted in patients with a major depressive
episode and were submitted to the Medicine Evaluation Board (1979-1991). The Medicine
Evaluation Board is the regulatory authority of the Netherlands.
A responder was defined as a patient with at least 50 % improvement on the Hamilton
Depression Rating Scale as compared to baseline score. A study responder was defined
as a patient meeting response criteria at endpoint (Last Observation Carried Forward).
A sustained responder was defined as a patient who, after becoming responder, remained
a responder until the end of the study.
Results : The ITT population incorporated 1989 patients in the tricyclic arm and 2042 patients
in the placebo arm. There was a statistically significant difference for study responders:
39.3 % in the tricyclic treatment group and 27.9 % in the placebo group (difference
11.4; CI95 % : 8.5 % ⇔ 14.3 %). However, no significant differences in sustained response patterns
were found, with the exception of a significantly higher sustained response rate for
initial responders at week 4.
Conclusions : While efficacy of tricyclic antidepressants was confirmed in this meta-analysis,
the sustained response patterns of active treatment and placebo did not differ substantially,
suggesting that many of the patients included in the studies were close to, or at
the end of, their episode.
References
JG.Storosum@CBG-MEB.nl
