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| Descriptive Information Fields | |||||||||
| Brief Title † | Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia | ||||||||
| Official Title † | Atypical Antipsychotics and P50 Sensory Gating | ||||||||
| Brief Summary | This study will examine the effects of ondansetron on auditory nerve activity in people with schizophrenia who are being treated with new antipsychotics. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | 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 ] |
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| Secondary Outcome Measure † | |||||||||
| Condition † | Schizophrenia | ||||||||
| Intervention † | Drug: Ondansetron Drug: Pill placebo Drug: Atypical antipsychotic drug |
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| MEDLINE PMIDs | 15677607, 15465979 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 90 | ||||||||
| Start Date † | January 2005 | ||||||||
| Completion Date | May 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00149734 | ||||||||
| Organization ID | R01 MH50787 | ||||||||
| Secondary IDs †† | COMIRB # 04-0255, DNBBS 73-MCR | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | September 6, 2005 | ||||||||
| Last Updated Date | March 4, 2008 | ||||||||
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