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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00149734 |
This study will examine the effects of ondansetron on auditory nerve activity in people with schizophrenia who are being treated with new antipsychotics.
Condition | Intervention |
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Schizophrenia |
Drug: Ondansetron Drug: Pill placebo Drug: Atypical antipsychotic drug |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Atypical Antipsychotics and P50 Sensory Gating |
Estimated Enrollment: | 90 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will take ondansetron then placebo plus an atypical antipsychotic drug
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Drug: Ondansetron
Participants will take 16 mg of ondansetron daily for either the first or second 3 months of the medication treatment period.
Drug: Pill placebo
Participants will take the pill placebo for either the first or second 3 months of medication treatment. The placebo pill will be administered in the same fashion as the active ondansetron pills.
Drug: Atypical antipsychotic drug
All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole.
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2: Experimental
Participants will take placebo then ondansetron plus an atypical antipsychotic drug
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Drug: Pill placebo
Participants will take the pill placebo for either the first or second 3 months of medication treatment. The placebo pill will be administered in the same fashion as the active ondansetron pills.
Drug: Atypical antipsychotic drug
All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole.
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Schizophrenia is a devastating brain disorder. Most people with schizophrenia have difficulty filtering out unimportant auditory information. They have an inability to appropriately inhibit, or gate, sensory information that enters the ear. Standard treatments do not address this problem. When the drug ondansetron is taken in addition to typical antipsychotic drugs, P50 auditory gating improves. However, ondansetron has not been used with some of the newer, atypical antipsychotic drugs. This study will evaluate the effect of combining ondansetron with newer, atypical antipsychotic drugs on P50 auditory gating.
Participants in this double-blind study will be randomly assigned to receive either ondansetron or placebo for 3 months. Upon completion of the first 3 months, participants will be crossed over to receive the other treatment for an additional 3 months. All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole. Auditory gating will be assessed using computerized cognitive testing and functional magnetic resonance imaging (fMRI) at baseline and Months 3 and 6. Vital signs and evoked potentials will be assessed at Weeks 1, 3, and 6. Clinical symptoms and cognitive abilities will also be evaluated to determine the effectiveness of ondansetron.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Merilyne C. Waldo, PhD | 303-399-8020 ext 2404 | merilyne.waldo@va.gov |
Contact: Laurie Woodward, BS | 303-393-5075 | Laurie.Woodward@med.va.gov |
United States, Colorado | |
Denver VAMC | Recruiting |
Denver, Colorado, United States, 80220 |
Principal Investigator: | Lawrence E. Adler, MD | University of Colorado Health Sciences Center, VISN19 MIRECC |
Responsible Party: | University of Colorado Health Sciences Center, Denver CO ( Lawrence Adler, MD ) |
Study ID Numbers: | R01 MH50787, COMIRB # 04-0255, DNBBS 73-MCR |
Study First Received: | September 6, 2005 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00149734 |
Health Authority: | United States: Federal Government |
Schizophrenia Ondansetron P50 sensory gating |
Evoked potentials 5-HT3 receptors Atypical antipsychotics |
Schizophrenia Quetiapine Mental Disorders Olanzapine Psychotic Disorders |
Ondansetron Aripiprazole Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics Antipsychotic Agents Pharmacologic Actions |
Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Antipruritics Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Dermatologic Agents |