Safety reporting in randomized trials of mental health interventions

Am J Psychiatry. 2004 Sep;161(9):1692-7. doi: 10.1176/appi.ajp.161.9.1692.


Objective: The authors aimed to evaluate the adequacy of the reporting of safety information in publications of randomized trials of mental-health-related interventions.

Method: The authors randomly selected 200 entries from the PsiTri registry of mental-health-related controlled trials. This yielded 142 randomized trials that were analyzed for adequacy and relative emphasis of their content on safety issues. They examined drug trials as well as trials of other types of interventions.

Results: Across the 142 eligible trials, 103 involved drugs. Twenty-five of the 142 trials had at least 100 randomly chosen subjects and at least 50 subjects in a study arm. Among drug trials, only 21.4% had adequate reporting of clinical adverse events, and only 16.5% had adequate reporting of laboratory-determined toxicity, while 32.0% reported both the numbers and the reasons for withdrawals due to toxicity in each arm. On average, drug trials devoted 1/10 of a page in their results sections to safety, and 58.3% devoted more space to the names and affiliations of authors than to safety. None of the trials of nondrug interventions had adequate or even partially adequate reporting of either clinical adverse events or laboratory-determined toxicity. In multivariate modeling, long-term trials and trials conducted in the United States devoted even less space to safety, while schizophrenia trials devoted more space to safety than did trials in other areas.

Conclusions: Safety reporting is largely neglected across trials of mental-health-related interventions, thus hindering the assessment of risk-benefit ratios for rational decision making in mental health care.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Decision Making
  • Humans
  • Mental Disorders / drug therapy
  • Mental Disorders / therapy*
  • Models, Statistical
  • Multivariate Analysis
  • Patient Dropouts / statistics & numerical data
  • Psychotropic Drugs / adverse effects
  • Psychotropic Drugs / therapeutic use
  • Publishing / standards*
  • Quality of Health Care / standards
  • Randomized Controlled Trials as Topic / adverse effects
  • Randomized Controlled Trials as Topic / standards*
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Registries
  • Regression Analysis
  • Research Design / standards*
  • Risk Assessment / standards
  • Safety Management / standards*
  • Schizophrenia / drug therapy
  • Schizophrenia / therapy
  • United States


  • Psychotropic Drugs