Mortality risk in patients with schizophrenia participating in premarketing atypical antipsychotic clinical trials.

Objective: Given the concern that mortality rates may be increased in geriatric patients exposed to atypical antipsychotic agents, we assessed mortality rates for adult patients with schizophrenia assigned to an investigational antipsychotic (olanzapine, quetiapine, risperidone, or ziprasidone), a control antipsychotic (haloperidol or chlorpromazine), or placebo in preapproval clinical development programs to assess relative risk with atypical antipsychotics as compared to typical antipsychotics or placebo.

Method: We reviewed safety data (from clinical trials conducted from approximately 1982 to 2002) for 16,791 adult patients with schizophrenia (DSM-III or DSM-IV criteria) in U.S.

The persistence of the placebo response in antidepressant clinical trials.

Our objective was to assess the persistence of the placebo response during at least 12 weeks of continued placebo administration in depressed patients who have responded to 6-8 weeks of acute placebo treatment. We identified 8 placebo-controlled antidepressant trials with a total of 3,063 depressed patients in which, after acute phase placebo treatment, placebo was continued for more than 12 weeks. The number of patients entering the continuation phase and percentages relapsing during this phase were determined.

Psychiatric diagnosis and clinical trial completion rates: analysis of the FDA SBA reports.

Completion rates may affect the safety and efficacy evaluations of psychotropics. We assessed completion rates in clinical trials evaluating psychotropics for five psychiatric disorders. We also examined differences in completion rates between psychotropics and placebo in each diagnostic category.