TY  - JOUR
PY  - 2005//
TI  - Suicide risk in placebo-controlled trials of treatment for acute manic episode and prevention of manic-depressive episode
JO  - American journal of psychiatry
A1  - Storosum, Jitschak G.
A1  - Wohlfarth, Tamar
A1  - Gispen-de Wied, Christine C.
A1  - Linszen, Don H.
A1  - Gersons, Berthold P. R.
A1  - van Zwieten, Barbara J.
A1  - van den Brink, Wim
SP  - 799
EP  - 802
VL  - 162
IS  - 4
N2  - OBJECTIVE: The authors' goal was to investigate whether there is a greater suicide risk in the placebo arms of placebo-controlled studies of active medication for the treatment of acute manic episode and the prevention of manic/depressive episode. If so, this would be a strong ethical argument against the conduct of such studies. METHOD: All placebo-controlled, double-blind, randomized trials of medication for the treatment of acute manic episode and the prevention of manic/depressive episode that were part of a registration dossier submitted to the regulatory authority of the Netherlands, the Medicines Evaluation Board, between 1997 and 2003, were reviewed for occurrence of suicide and attempted suicide. RESULTS: In 11 placebo-controlled studies of the treatment of acute manic episode, including 1,506 patients (117 person-years) in the combined active compound group and 1,005 patients (71 person-years) in the combined placebo group, no suicides and no suicide attempts occurred. In four placebo-controlled studies of the prevention of manic/depressive episode, including 943 patients (406 person-years) in the combined active compound group and 418 patients (136 person-years) in the combined placebo group, two suicides (493/100,000 person-years of exposure) and eight suicide attempts (1,969/100,000 person-years of exposure) occurred in the combined active compound group, but no suicides and two suicide attempts (1,467/100,000 person-years of exposure) occurred in the combined placebo group. CONCLUSIONS: Concern about greater risk of suicide or attempted suicide in the placebo group should not be an argument against the conduct of placebo-controlled trials for these indications, provided that appropriate precautions are taken.<p /> <p>Language: en</p>
LA  - en
SN  - 0002-953X
UR  - http://dx.doi.org/10.1176/appi.ajp.162.4.799
ID  - ref1
ER  -