Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
Schizophrenia |
Drug: Ondansetron Drug: Pill placebo Drug: Atypical antipsychotic drug |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Atypical Antipsychotics and P50 Sensory Gating |
- P50 sensory gating [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
- Cognitive testing [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
Participants will take ondansetron then placebo plus an atypical antipsychotic drug
|
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.
|
|
Experimental: 2
Participants will take placebo then ondansetron plus an atypical antipsychotic drug
|
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meets DSM-IV criteria for schizophrenia
- Stable, chronic schizophrenia
- Currently taking atypical medications
- Use of effective form of contraception throughout study
Exclusion Criteria:
- History of any alcohol or drug abuse within 3 months of study start date
- Any other major neurological disorders
- History of or current head trauma
- Any medical conditions affecting the central nervous system
- Current epilepsy, asthma, migraine headache, previous myocardial infarction, stroke, diabetes, hypertension, narrow angle glaucoma, or neuromuscular illnesses
- Pregnant
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00149734
| 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 |
More Information
Publications:
| Responsible Party: | Lawrence Adler, MD, University of Colorado Health Sciences Center, Denver CO |
| ClinicalTrials.gov Identifier: | NCT00149734 History of Changes |
| Other Study ID Numbers: | R01 MH50787, COMIRB # 04-0255, DNBBS 73-MCR |
| Study First Received: | September 6, 2005 |
| Last Updated: | March 4, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Schizophrenia Ondansetron P50 sensory gating |
Evoked potentials 5-HT3 receptors Atypical antipsychotics |
Additional relevant MeSH terms:
|
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features Antipsychotic Agents Ondansetron Anti-Anxiety Agents Antiemetics Antipruritics Autonomic Agents Central Nervous System Agents Central Nervous System Depressants Dermatologic Agents |
Gastrointestinal Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Antagonists Therapeutic Uses Tranquilizing Agents |
ClinicalTrials.gov processed this record on March 03, 2015