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.

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.

Seizure incidence in psychopharmacological clinical trials: an analysis of Food and Drug Administration (FDA) summary basis of approval reports.

Background: Clinical trial data provide an approach to the investigation of the effects of psychopharmacological agents, and psychiatric disorders themselves, on seizure threshold.

Methods: We accessed public domain data from Food and Drug Administration (FDA) Phase II and III clinical trials as Summary Basis of Approval (SBA) reports that noted seizure incidence in trials of psychotropic drugs approved in the United States between 1985 and 2004, involving a total of 75,873 patients. We compared seizure incidence among active drug and placebo groups in psychopharmacological clinical trials and the published rates of unprovoked seizures in the general population.

Relationship between depression severity entry criteria and antidepressant clinical trial outcomes.

Background: We assessed whether increasing the minimum prerandomization Hamilton Depression Rating Scale (HAM-D) score to enrich the severity of the depressed sample affects antidepressant trial outcome.

Methods: Using the Food and Drug Administration Summary Basis of Approval reports, we examined outcome data from 51 clinical trials (11,270 depressed patients) evaluating 10 investigational antidepressants.

Results: Using four categories of trials with increasing minimum HAM-D entry trial criteria, we found no statistically significant relationship between prerandomization categories and trial outcome overall.

BMI, sex, and antidepressant response.

Background: Investigators have examined potential mechanisms for the observed differences between men and women in antidepressant response. However, to date no studies have measured the impact of body mass index (BMI) on men's and women's response to selective serotonin re-uptake inhibitors or placebo.

Methods: We evaluated the response to antidepressants and placebo of 274 non-obese (BMI<30) and obese (BMI>30) depressed outpatients participating in Phase II-IV clinical trials.

Sex differences in antidepressant response in recent antidepressant clinical trials.

Some previous reports suggest that women respond differently than men to antidepressant treatment. Much of this literature compares men and women's response to tricyclics to that of newer antidepressants (SSRIs, SNRI), or only examines one particular antidepressant. This study compares men and women's responses to 6 newer antidepressants.

Magnitude of placebo response and drug-placebo differences across psychiatric disorders.

Background: Placebo response, drug response, and drug-placebo differences appear to vary among psychiatric conditions.

Method: We evaluated the Food and Drug Administration (FDA) Summary Basis of Approval (SBA) reports to compare the magnitude of placebo response, magnitude of psychotopic drug response, and drug placebo differences among various diagnostic groups such as depression, anxiety, and psychotic disorders.

Results: Six diagnostic groups (psychosis, obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD), depression, post-traumatic stress disorder, panic) varied in response to both placebo and active drug treatments.

Severity of depressive symptoms and response to antidepressants and placebo in antidepressant trials.

Although increased pre-treatment severity of depressive symptoms is thought to suggest better outcome with tricyclic antidepressants, it is unclear if such a pattern exists among those depressed patients treated with newer antidepressants. If such a pattern with newer antidepressants were observed, it would have implications for the design and conduct of future antidepressant trials. We reviewed the data from 329 depressed adult patients that were part of 15 multi-center, randomized, double blind, placebo-controlled antidepressant clinical trials at our center.

Research design features and patient characteristics associated with the outcome of antidepressant clinical trials.

Objective: The authors examined which, if any, research design features and patient characteristics would significantly differ between successful and unsuccessful antidepressant trials.

Method: Clinical trial data were reviewed for nine antidepressants approved by the Food and Drug Administration between 1985 and 2000. From the antidepressant research programs on these medications, 52 clinical trials were included in the study.

Relative sensitivity of the Montgomery-Asberg depression rating scale, the Hamilton depression rating scale and the Clinical Global Impressions rating scale in antidepressant clinical trials: a replication analysis.

The present study replicates a previous study in which we found that the less frequently used Montgomery-Asberg Depression Rating Scale (MADRS) is as sensitive an instrument in detecting antidepressant-placebo differences in antidepressant clinical trials as the more widely used Hamilton Depression (HAM-D) rating scale. The Clinical Global Impressions Rating Scale for Severity (CGI-S) was also similar to the other two scales. A retrospective chart review was performed on the records of 139 depressed adult patients who participated in six randomized, placebo-controlled, double-blind antidepressant clinical trials at the North-west Clinical Research Centre between 1996 and 2003.

The relationship of sociotropy and autonomy to posttraumatic cognitions and PTSD symptomatology in trauma survivors.

The current study examined relationships between sociotropic and autonomous personality styles and posttraumatic stress disorder (PTSD) symptomatology following trauma as well as specific posttraumatic cognitions that have been shown to characterize individuals with PTSD. Self-report data were collected in a sample of 156 college students indicating a history of traumatic experience. Significant relationships were found between symptoms of PTSD and depression and measures of sociotropy, autonomy, and negative posttraumatic beliefs about self and world.