Suicide risk analysis among patients assigned to psychotropics and placebo.
Based on available data, it is unclear if the suicide risk is significantly different among clinical trial patients assigned to psychotropics compared with patients assigned to placebo, among patients with various psychiatric diagnoses. This study was to investigate whether patients assigned to psychotropics would have a similar suicide risk as measured by the frequency of completed suicides and suicide attempts, compared to those patients assigned to placebo. The U.S. Food and Drug Administration database of controlled clinical trials for 9 antidepressants, 3 antipsychotics, and 7 anxiolytics provided data for comparing suicides and suicide attempts among 46,575 patients assigned to psychotropics or placebo. The Poisson Regression analysis suggested that there were no significant differences in rates of suicide and suicide attempts among patients assigned to the psychotropics or placebo. These findings suggest that the high suicide risk among clinical trial participants is not significantly affected by psychotropics.
Khan
Arif
A
Northwest Clinical Research Center, Bellevue, WA 98004, USA. akhan@nwcrc.net
Kolts
Russell L
RL
Brodhead
Amy E
AE
Krishnan
K Ranga
KR
Brown
Walter A
WA
D014151:Anti-Anxiety Agents / Q000009:adverse effects / Q000627:therapeutic use; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use; D018849:Controlled Clinical Trials as Topic; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy* / Q000401:mortality; D016012:Poisson Distribution; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000627:therapeutic use; D012306:Risk; D013405:Suicide / Q000706:statistics & numerical data*; D013406:Suicide, Attempted / Q000706:statistics & numerical data*; D014481:United States
D014151:Anti-Anxiety Agents; D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D011619:Psychotropic Drugs