Back to resultsSerotonin 1A Agonists and Cognition in Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
adjunctive treatment with buspirone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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
Sites / Locations
- Psychiatric Hospital at Vanderbilt
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
buspirone 15-30 mg qd
placebo
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00178971
First Posted
September 12, 2005
Last Updated
June 5, 2017
Sponsor
Northwestern University
Collaborators
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT00178971
Brief Title
Serotonin 1A Agonists and Cognition in Schizophrenia
Official Title
Serotonin 1A Agonists and Cognition in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Alliance for Research on Schizophrenia and Depression
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
buspirone 15-30 mg qd
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
adjunctive treatment with buspirone
Intervention Description
buspirone 15-30 mg qd
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Y Meltzer, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Serotonin 1A Agonists and Cognition in Schizophrenia
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