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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00178971
Other study ID # 020724
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated June 5, 2017
Start date January 2003
Est. completion date October 2004

Study information

Verified date June 2017
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Intervention

Drug:
adjunctive treatment with buspirone
buspirone 15-30 mg qd
placebo
placebo

Locations

Country Name City State
United States Psychiatric Hospital at Vanderbilt Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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