Serotonin 1A Agonists and Cognition in Schizophrenia
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ClinicalTrials.gov Identifier: NCT00178971 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : June 7, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia Schizoaffective Disorder | Drug: adjunctive treatment with buspirone Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | January 2003 |
Actual Primary Completion Date : | October 2004 |
Actual Study Completion Date : | October 2004 |

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 |
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
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.
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178971
United States, Tennessee | |
Psychiatric Hospital at Vanderbilt | |
Nashville, Tennessee, United States, 37212 |
Principal Investigator: | Herbert Y Meltzer, M.D. | Vanderbilt University Medical Center |
Responsible Party: | Herbert Meltzer, Professor, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00178971 |
Other Study ID Numbers: |
020724 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | June 7, 2017 |
Last Verified: | June 2017 |
Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Buspirone Anti-Anxiety Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |