Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00149734|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Ondansetron followed by placebo Drug: Placebo followed by Ondansetron||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Atypical Antipsychotics and P50 Sensory Gating|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Experimental: Ondansetron followed by placebo
Participants will take ondansetron then placebo plus an atypical antipsychotic drug
Drug: Ondansetron followed by placebo
Participants will take 16mg of ondansetron daily for the first three months followed by 3 months of placebo. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.
Other Name: Zofran, Zuplenz
Experimental: Placebo followed by Ondansetron
Participants will take placebo then ondansetron plus an atypical antipsychotic drug
Drug: Placebo followed by Ondansetron
Participants will take placebo daily for the first three months followed by 3 months of 16mg of ondansetron daily. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.
Other Name: Zofran, Zuplenz
- P50 sensory gating [ Time Frame: Measured at Months 3 and 6 ]
- Cognitive testing [ Time Frame: Measured at Months 3 and 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149734
|United States, Colorado|
|Denver, Colorado, United States, 80220|
|Principal Investigator:||Lawrence E. Adler, MD||University of Colorado Health Sciences Center, VISN19 MIRECC|