Serotonin 1A Agonists and Cognition in Schizophrenia

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00178971
• Collaborator: National Alliance for Research on Schizophrenia and Depression (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder	Drug: adjunctive treatment with buspirone; Drug: placebo	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• 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
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Oct 1, 2004
• Actual Study Completion Date: Oct 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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 [six weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Herbert Meltzer, Professor, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT00178971
• Other Study ID Numbers: 020724
• First Posted: Sep 15, 2005
• Last Update Posted: Jun 7, 2017
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders; Buspirone

Study Results

No Results Posted as of Jun 7, 2017