Serotonin 1A Agonists and Cognition in Schizophrenia - Full Text View

Sponsors and Collaborators:	Vanderbilt University National Alliance for Research on Schizophrenia and Depression
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00178971

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 III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Serotonin Buspirone Buspirone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Serotonin 1A Agonists and Cognition in Schizophrenia

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
1: Active Comparator buspirone 15-30 mg qd	Drug: adjunctive treatment with buspirone buspirone 15-30 mg qd
2: Placebo Comparator 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.

Subjects will be males and females between 18-65 years of age;
Subjects will have a definite diagnosis by DSM-IV criteria for Schizophrenia or Schizoaffective Disorder;
The subjects or their legal guardian must sign the informed consent;
Subjects currently being treated with olanzapine or risperidone for a duration of at least 3 months

Exclusion Criteria:

Subjects who are pregnant or lactating
Subjects who have brain damage and/or neurological disorders
Subjects who have current substance dependence
Subjects unable to provide informed consent

Contacts and Locations

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

Responsible Party:	Vanderbilt University Medical Center ( Herbert Meltzer, M.D. )
Study ID Numbers:	020724
Study First Received:	September 12, 2005
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00178971
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Buspirone
Schizophrenia
Mental Disorders

Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Tranquilizing Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Anti-Anxiety Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009