title: The international suicide prevention trial (interSePT): rationale and design of a trial comparing the relative ability of clozapine and olanzapine to reduce suicidal behavior in schizophrenia and schizoaffective patients.
abstract: Suicidal behavior in patients with psychotic disorders represents a seriously undertreated life-threatening condition. The International Suicide Prevention Trial (InterSePT) is the first large-scale, prospective study designed to evaluate the potential of antipsychotic medications to reduce suicidal behaviors in patients with schizophrenia or schizoaffective disorder who are known to be at high risk for suicide. The unique challenges to study design and the solutions identified for the InterSePT study are described. These challenges included defining suicidal behavior in patients with psychosis, endpoint selection, determination of analytic strategy, and development of scales to assess suicidal behavior. Given the life-threatening nature of suicidal behavior, ethical considerations required that the design minimize suicide attempts and deaths. While the study focused primarily on treatment of suicide, opportunities were used to collect data in related areas of interest, including suicide risk factors, other efficacy measures (e.g., Positive and Negative Syndrome Scale, Covi Anxiety Scale, Calgary Depression Scale), adverse events, pharmacoeconomics, and pharmacogenetics. Because of the complexity of the design issues, a steering committee, suicide monitoring board, and publication committee were established to assist with their management.
authors.affiliation: larry.alphs@pfizer.com
authors.forename: Larry
authors.initials: L
authors.lastname: Alphs
authors.forename: Ravi
authors.initials: R
authors.lastname: Anand
authors.forename: M Zahur
authors.initials: MZ
authors.lastname: Islam
authors.forename: Herbert Y
authors.initials: HY
authors.lastname: Meltzer
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
authors.forename: Ranga
authors.initials: R
authors.lastname: Krishnan
authors.forename: Alan I
authors.initials: AI
authors.lastname: Green
authors.forename: Steven
authors.initials: S
authors.lastname: Potkin
authors.forename: Guy
authors.initials: G
authors.lastname: Chouinard
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lindenmayer
authors.forename: Rob
authors.initials: R
authors.lastname: Kerwin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000494:pharmacology / Q000627:therapeutic use*; D003024:Clozapine / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D011618:Psychotic Disorders / Q000150:complications / Q000188:drug therapy*; D012107:Research Design; D012307:Risk Factors; D012559:Schizophrenia / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome; D000092864:Suicide Prevention
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D003024:Clozapine; D000077152:Olanzapine