Decreased suicide rates in recent antidepressant clinical trials

Rationale The last systematic analysis of suicidality in antidepressant clinical trials submitted for approval by the US Food and Drug Administration was in 2000. Given the attention to suicide and antidepressants in the early 2000s, the authors aimed to evaluate if there have been any changes in su...

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Bibliographic Details
Published in:Psychopharmacology 2018-05, Vol.235 (5), p.1455-1462
Main Authors: Khan, Arif, Fahl Mar, Kaysee, Gokul, Sagarika, Brown, Walter A.
Format: Article
Language:English
Subjects:
Adult
Antidepressants
Antidepressive Agents - therapeutic use
Biomedical and Life Sciences
Biomedicine
Clinical outcomes
Clinical trials
Clinical Trials as Topic - methods
Databases, Factual - trends
Demographics
Depression (Mood disorder)
Depression - drug therapy
Depression - epidemiology
Depression - psychology
Evaluation
Exposure
FDA approval
Female
Humans
Male
Medical schools
Mental depression
Middle Aged
Neurosciences
Original Investigation
Pharmacology/Toxicology
Product development
Psychiatry
Regression analysis
Risk Factors
Statistical analysis
Statistics
Suicidal behavior
Suicidal Ideation
Suicide
Suicide, Attempted - prevention & control
Suicide, Attempted - psychology
Suicide, Attempted - trends
Suicides & suicide attempts
United States - epidemiology
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Summary:Rationale The last systematic analysis of suicidality in antidepressant clinical trials submitted for approval by the US Food and Drug Administration was in 2000. Given the attention to suicide and antidepressants in the early 2000s, the authors aimed to evaluate if there have been any changes in suicide rates in antidepressant clinical trials following 2000. Objective and Methods The Integrated Safety Summary data from approval packets for 14 investigational antidepressant programs (1991–2013, 40,857 patients, 10,890.5 exposure years) were used to calculate suicides and suicide attempts per 100,000 patient exposure years (standardized rates) for antidepressant and placebo treatment groups separately. Suicides/suicide attempt rates, mean age, and percent female were compared between 1991 and 1998 (pre-2000) and 2002–2013 (post-2000). Drug-placebo differences in suicide/suicide attempt rates were explored. Results Among antidepressant-treated patients, the standardized suicide rate decreased significantly from pre- to post-2000 (643.6 to 25.8, p  
ISSN:0033-3158
1432-2072
DOI:10.1007/s00213-018-4856-1