Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 10/18/2018 |
| Start Date: | January 2005 |
| End Date: | May 2010 |
Atypical Antipsychotics and P50 Sensory Gating
This study will examine the effects of ondansetron on auditory nerve activity in people with
schizophrenia who are being treated with new antipsychotics.
schizophrenia who are being treated with new antipsychotics.
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.
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.
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
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