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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
History of Changes

September 6, 2005
March 4, 2008
January 2005
February 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • P50 sensory gating; measured at Months 3 and 6
  • Cognitive testing; measured at Months 3 and 6
  • Clinical symptoms; measured at Months 3 and 6
Complete list of historical versions of study NCT00149734 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia
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 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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: 1
    Participants will take ondansetron then placebo plus an atypical antipsychotic drug
    Interventions:
    • Drug: Ondansetron
    • Drug: Pill placebo
    • Drug: Atypical antipsychotic drug
  • Experimental: 2
    Participants will take placebo then ondansetron plus an atypical antipsychotic drug
    Interventions:
    • Drug: Pill placebo
    • Drug: Atypical antipsychotic drug

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
May 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
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
United States
 
NCT00149734
R01 MH50787, COMIRB # 04-0255, DNBBS 73-MCR
No
Lawrence Adler, MD, University of Colorado Health Sciences Center, Denver CO
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Lawrence E. Adler, MD University of Colorado Health Sciences Center, VISN19 MIRECC
National Institute of Mental Health (NIMH)
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP