Official Title: “Serotonin 1A Agonists and Cognition in Schizophrenia”

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 antispycotic medication for six weeks. Patients' memory and problem-solving ability will be tested before and after medication.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2004

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • buspirone 15-30 mg qd
• Placebo Comparator: 2
  • placebo

Primary Measures

• 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
  • Time Frame: six weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Vanderbilt University

Overall Clinical Trial Officials and Contacts

Herbert Y Meltzer, M.D. Principal Investigator Vanderbilt University  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00178971

Study ID Number: 020724

ClinicalTrials.gov Identifier: NCT00178971

Health Authority: United States: Food and Drug Administration