Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia
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About
This study will examine the effects of ondansetron on auditory nerve activity in people with schizophrenia who are being treated with new antipsychotics.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
8 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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