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

History of Changes

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:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Serotonin Buspirone hydrochloride Buspirone

U.S. FDA Resources

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 (Adult)
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

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


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:


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

ClinicalTrials.gov processed this record on September 27, 2016

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