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Serotonin 1A Agonists and Cognition in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178971
First Posted: September 15, 2005
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Herbert Meltzer, Vanderbilt University
  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 antipsychotic 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
Intervention Model: Parallel Assignment
Masking: Quadruple (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 Herbert Meltzer, 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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178971


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

Responsible Party: Herbert Meltzer, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00178971     History of Changes
Other Study ID Numbers: 020724
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: June 7, 2017
Last Verified: June 2017

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


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