Suicide risk in placebo-controlled trials of treatment for acute manic episode and prevention of manic-depressive episode.
Storosum JG, Wohlfarth T, Gispen-de Wied CC, Linszen DH, Gersons BP, van Zwieten BJ, van den Brink W.
SourceMedicines Evaluation Board of the Netherlands, Kalvermarkt 53, PO-BOX 16229, 2500 BE Den Haag, The Netherlands. JG.Storosum@CBG-MEB.nl
Abstract
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.
The above is pure "copy cat" from : http://www.ncbi.nlm.nih.gov/pubmed/15800158
CONCLUSIONS ? How about Bipolar medication causes more suicide than it prevents !!!
Isnt that sick, they KILLED two people and then write: "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 ..."
Hello, the evidence is you killed 2 people.