Serotonin 1A Agonists and Cognition in Schizophrenia

NCT ID: NCT00178971

Last Updated: 2017-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-10-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

buspirone 15-30 mg qd

Group Type ACTIVE_COMPARATOR

adjunctive treatment with buspirone

Intervention Type DRUG

buspirone 15-30 mg qd

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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adjunctive treatment with buspirone

buspirone 15-30 mg qd

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Herbert Meltzer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Herbert Y Meltzer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Psychiatric Hospital at Vanderbilt

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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020724

Identifier Type: -

Identifier Source: org_study_id

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