Table of Contents
International Suicide Prevention Trial InterSePT Study Design Efficacy and Safety Results
InterSePT: Overview of Presentation
International Suicide Prevention Trial (InterSePT): Objective
Study Design
Study Schematic
Patient Selection Criteria
Choice of Comparison Medication
Rationale for Open-Label Design
Primary Efficacy Endpoint
Type 1 Event
Suicide Attempt
Type 2 Event
Secondary Efficacy Assessments
Data Flow: Determination of Suicide Attempt/Hospitalization to Prevent Suicide
Independent Suicide Monitoring Board (SMB)
SMB: Members
SMB: Role
SMB: Material Used in Determination of Type 1 Events
SMB: Cases Reviewed for Determination of Type 1 Events
Suicide Monitoring Board: Summary
Statistical Methods
Primary Efficacy Analysis
Supportive Analyses
Sample Size
InterSePT Results
InterSePT Study Centers and Dates
Patient Disposition
Demographics at Baseline
Diagnosis and History of Treatment Resistance
Clinical Characteristics at Baseline
Study Discontinuations
Study Medication: Total Daily Dose
InterSePT Results
Patients Experiencing SMB-Determined Type 1 Events: Suicide Attempts and Hospitalizations
Distribution of Patients by Number of Suicide Attempts or Hospitalizations to Prevent Suicide
Patients Experiencing Type 2 Events: Worsening of Suicidality, Suicide Attempt, Hospitalization to Prevent Suicide
Results of WLW and Cox’s Analyses
Kaplan-Meier Estimates of Cumulative Probabilities of a Type 1 or Type 2 Event
Cox’s Analyses of Type 1 Events by Subgroups
InterSePT Results
Change in Severity of Suicidality CGI-SS-BP at Week 104
LS Mean Change From Baseline ISST-BP, PANSS-T, CDS and Covi at Week 104
LS Mean Daily Dose (mg) of Concomitant Psychotropic Medications
Safety
Incidence of Adverse Events and Serious Adverse Events
Clozaril® Adverse Events of Interest
Zyprexa® Adverse Events of Interest
Neuropsychiatric Adverse Events
Deaths
Examination of the Process of Referral of Potential Type 1 Events to the SMB
InterSePT Design: Potential Bias in Referrals to SMB
Method to Review the Process of Referral of Potential Type 1 Events to SMB
Review of Referral Process: Summary of Findings
Conclusions From InterSePT (1)
Conclusions From InterSePT (2)
Overall Conclusion
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