Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

Condition(s) targeted: Prodromal Schizophrenia; Psychotic Disorders

Intervention: risperidone (Drug); sertraline-primary (Drug)

Phase: N/A

Status: Completed

Sponsored by: North Shore Long Island Jewish Health System

Official(s) and/or principal investigator(s):
Barbara A Cornblatt, PhD, Principal Investigator, Affiliation: Long Island Jewish Medical Center (LIJMC)
Christoph U Correll, MD, Study Director, Affiliation: LIJMC

The Recognition and Prevention (RAP) Program is conducting a research study comparing an antidepressant, sertraline, alone versus in combination with a second-generation antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts, suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention and social skills in adolescents.

Official title: Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms

Study design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Score on attenuated positive symptom scale at 16 weeks

Score on attenuated negative symptom scale at 16 weeks

Secondary outcome:

Score on social functioning measure at 16 weeks

Score on academic functioning measure at 16 weeks

Score on cognitive measures at 16 weeks

Detailed description: Eligible patients are enrolled in a 16-week trial consisting of symptom and side effects ratings (10 visits), monthly blood and urine tests, and neuropsychological testing at the first and last visits. At the initial appointment, all patients are assigned to sertraline and are randomly assigned to an adjunctive risperidone or placebo group. The treating physician is also blind to the medication assignment, which allows both the doctor and the patient to assess side effects and symptom improvement, unbiased by expectation. All patients receive an active medication.

Minimum age: 12 Years. Maximum age: 22 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Participants are between the ages of 12 and 22. Participants are English-speaking. Participants are experiencing one or more symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences. Participants meet additional RAP criteria (evaluated during screening and interview). Exclusion Criteria: Participants have been diagnosed with an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features. Participants have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain. Participants have a medical condition that contraindicates treatment with sertraline or risperidone. Participants have past or current substance dependence. Participants are currently taking and responding well to antidepressant or antipsychotic medication

RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, New York 11004, United States

RAP Program Homepage

Starting date: March 2004
Ending date: April 2007
Last updated: October 17, 2007