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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Ondansetron followed by placebo Drug: Placebo followed by Ondansetron Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. P50 sensory gating [ Time Frame: Measured at Months 3 and 6 ]
  2. Cognitive testing [ Time Frame: Measured at Months 3 and 6 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Information from the National Library of Medicine

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


Locations
United States, Colorado
Denver VAMC
Denver, Colorado, United States, 80220
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Lawrence E. Adler, MD University of Colorado Health Sciences Center, VISN19 MIRECC
More Information
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Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00149734     History of Changes
Other Study ID Numbers: 04-0255
R01MH050787 ( U.S. NIH Grant/Contract )
COMIRB # 04-0255
DNBBS 73-MCR
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Colorado, Denver:
Schizophrenia
Ondansetron
P50 sensory gating
 Evoked potentials
5-HT3 receptors
Atypical antipsychotics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Ondansetron
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents