Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

Sponsor

Northwell Health (Other)

Overall Status

Completed

CT.gov ID

NCT00169988

Collaborator

Stanley Medical Research Institute (Other), Janssen Pharmaceutica N.V., Belgium (Industry), Pfizer (Industry)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prodromal Schizophrenia Psychotic Disorders	Drug: risperidone Drug: sertraline-primary	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Mar 1, 2004

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Score on attenuated positive symptom scale at 16 weeks []
Score on attenuated negative symptom scale at 16 weeks []

Secondary Outcome Measures

Score on social functioning measure at 16 weeks []
Score on academic functioning measure at 16 weeks []
Score on cognitive measures at 16 weeks []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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