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Serotonin 1A Agonists and Cognition in Schizophrenia

This study has been completed.
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Vanderbilt University Identifier:
First received: September 12, 2005
Last updated: January 6, 2010
Last verified: January 2010
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.

Condition Intervention Phase
Schizoaffective Disorder
Drug: adjunctive treatment with buspirone
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Serotonin 1A Agonists and Cognition in Schizophrenia

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome 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 ]

Enrollment: 60
Study Start Date: January 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
buspirone 15-30 mg qd
Drug: adjunctive treatment with buspirone
buspirone 15-30 mg qd
Placebo Comparator: 2
Drug: placebo

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00178971

United States, Tennessee
Psychiatric Hospital at Vanderbilt
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Herbert Y Meltzer, M.D. Vanderbilt University Medical Center
  More Information

Responsible Party: Herbert Meltzer, M.D., Vanderbilt University Medical Center Identifier: NCT00178971     History of Changes
Other Study ID Numbers: 020724
Study First Received: September 12, 2005
Last Updated: January 6, 2010

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017