Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

risperidone

sertraline-primary

About this trial

This is an interventional diagnostic trial for Prodromal Schizophrenia focused on measuring clinical high risk, attenuated positive symptoms, attenuated negative symptoms, cognition, functional status, prodromal psychosis

Eligibility Criteria

12 Years - 22 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital

Outcomes

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

Full Information

NCT ID

NCT00169988

First Posted

September 9, 2005

Last Updated

December 16, 2009

Sponsor

Northwell Health

Collaborators

Stanley Medical Research Institute, Janssen Pharmaceutica N.V., Belgium, Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00169988

Brief Title

Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Northwell Health

Collaborators

Stanley Medical Research Institute, Janssen Pharmaceutica N.V., Belgium, Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prodromal Schizophrenia, Psychotic Disorders

Keywords

clinical high risk, attenuated positive symptoms, attenuated negative symptoms, cognition, functional status, prodromal psychosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

risperidone

Intervention Type

Drug

Intervention Name(s)

sertraline-primary

Primary Outcome Measure Information:

Title

Score on attenuated positive symptom scale at 16 weeks

Title

Score on attenuated negative symptom scale at 16 weeks

Secondary Outcome Measure Information:

Title

Score on social functioning measure at 16 weeks

Title

Score on academic functioning measure at 16 weeks

Title

Score on cognitive measures at 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara A Cornblatt, PhD

Organizational Affiliation

Long Island Jewish Medical Center (LIJMC)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christoph U Correll, MD

Organizational Affiliation

LIJMC

Official's Role

Study Director

Facility Information:

Facility Name

RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital

City

Glen Oaks

State/Province

New York

ZIP/Postal Code

11004

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.rapprogram.org/

Description

RAP Program Homepage

Prodromal Schizophrenia, Psychotic Disorders

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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