Serotonin 1A Agonists and Cognition in Schizophrenia

NCT00178971 | Completed Phase 3

• 1 other identifier: 020724
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (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

Study Arms (2)

1

ACTIVE COMPARATOR

buspirone 15-30 mg qd

Drug: adjunctive treatment with buspirone

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

adjunctive treatment with buspirone DRUG

buspirone 15-30 mg qd

1

placebo DRUG

placebo

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Psychiatric Hospital at Vanderbilt

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Study Officials

• Herbert Y Meltzer, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: June 7, 2017

Record last verified: 2017-06

Locations

US (1)