Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

Psychotic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169988
• Other study ID #: 05-04-103
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: December 16, 2009
• Start date: March 2004
• Est. completion date: April 2007

Study information

• Verified date: October 2007
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 22 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Mental Disorders
• Prodromal Schizophrenia
• Psychotic Disorders
• Schizotypal Personality Disorder

Intervention

Drug:
• risperidone

• sertraline-primary

Locations

Country	Name	City	State
United States	RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (4)

Lead Sponsor	Collaborator
Northwell Health	Janssen Pharmaceutica N.V., Belgium, Pfizer, Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on attenuated positive symptom scale at 16 weeks
Primary	Score on attenuated negative symptom scale at 16 weeks
Secondary	Score on social functioning measure at 16 weeks
Secondary	Score on academic functioning measure at 16 weeks
Secondary	Score on cognitive measures at 16 weeks

External Links

•   RAP Program Homepage