Serotonin 1A Agonists and Cognition in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178971
First received: September 12, 2005
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

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
Schizophrenia
Schizoaffective Disorder
Drug: adjunctive treatment with buspirone
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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
placebo
Drug: placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178971

Locations
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
Investigators
Principal Investigator: Herbert Y Meltzer, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Herbert Meltzer, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00178971     History of Changes
Other Study ID Numbers: 020724
Study First Received: September 12, 2005
Last Updated: January 6, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Buspirone
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 09, 2014