Trial record 1 of 1 for:    NCT00149734
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Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00149734
First received: September 6, 2005
Last updated: March 4, 2008
Last verified: March 2008
  Purpose

This study will examine the effects of ondansetron on auditory nerve activity in people with schizophrenia who are being treated with new antipsychotics.


Condition Intervention
Schizophrenia
Drug: Ondansetron
Drug: Pill placebo
Drug: Atypical antipsychotic drug

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atypical Antipsychotics and P50 Sensory Gating

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: January 2005
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will take ondansetron then placebo plus an atypical antipsychotic drug
Drug: Ondansetron
Participants will take 16 mg of ondansetron daily for either the first or second 3 months of the medication treatment period.
Drug: Pill placebo
Participants will take the pill placebo for either the first or second 3 months of medication treatment. The placebo pill will be administered in the same fashion as the active ondansetron pills.
Drug: Atypical antipsychotic drug
All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole.
Experimental: 2
Participants will take placebo then ondansetron plus an atypical antipsychotic drug
Drug: Pill placebo
Participants will take the pill placebo for either the first or second 3 months of medication treatment. The placebo pill will be administered in the same fashion as the active ondansetron pills.
Drug: Atypical antipsychotic drug
All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149734

Contacts
Contact: Merilyne C. Waldo, PhD 303-399-8020 ext 2404 merilyne.waldo@va.gov
Contact: Laurie Woodward, BS 303-393-5075 Laurie.Woodward@med.va.gov

Locations
United States, Colorado
Denver VAMC Recruiting
Denver, Colorado, United States, 80220
Sponsors and Collaborators
Investigators
Principal Investigator: Lawrence E. Adler, MD University of Colorado Health Sciences Center, VISN19 MIRECC
  More Information

Publications:
Responsible Party: Lawrence Adler, MD, University of Colorado Health Sciences Center, Denver CO
ClinicalTrials.gov Identifier: NCT00149734     History of Changes
Other Study ID Numbers: R01 MH50787, COMIRB # 04-0255, DNBBS 73-MCR
Study First Received: September 6, 2005
Last Updated: March 4, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Schizophrenia
Ondansetron
P50 sensory gating
Evoked potentials
5-HT3 receptors
Atypical antipsychotics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Ondansetron
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on April 17, 2014