Serotonin 1A Agonists and Cognition in Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: adjunctive treatment with buspirone; Drug: placebo

• Registration Number: NCT00178971
• Lead Sponsor: Northwestern University

Brief Summary

Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with antipsychotic medications. Patients will be assigned to take active medication (Buspar)or placebo along with their prescribed antipsychotic medication for six weeks. Patients' memory and problem-solving ability will be tested before and after medication.

Detailed Description

Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with olanzapine or risperidone for at least three months randomized to receive adjunctive treatment with a 5-HT1A agonist (buspirone, 15-30 mg/day)or placebo.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-05
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Subjects must meet all of the following criteria to be eligible for participation in the current research study.

1. Subjects will be males and females between 18-65 years of age;
2. Subjects will have a definite diagnosis by DSM-IV criteria for Schizophrenia or Schizoaffective Disorder;
3. The subjects or their legal guardian must sign the informed consent;
4. Subjects currently being treated with olanzapine or risperidone for a duration of at least 3 months

Exclusion Criteria

1. Subjects who are pregnant or lactating
2. Subjects who have brain damage and/or neurological disorders
3. Subjects who have current substance dependence
4. Subjects unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	adjunctive treatment with buspirone	buspirone 15-30 mg qd
2	placebo	placebo

Primary Outcome Measures

Name	Time	Method
This study will examine the effect on cognition of the addition of buspirone compared with addition of a sugar pill to patients treated with olanzapine or risperidone	six weeks

Trial Locations

Locations (1)

Psychiatric Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States