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Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00149734
First received: September 6, 2005
Last updated: May 12, 2017
Last verified: May 2017
September 6, 2005
May 12, 2017
January 2005
May 2010   (Final data collection date for primary outcome measure)
  • P50 sensory gating [ Time Frame: Measured at Months 3 and 6 ]
  • Cognitive testing [ Time Frame: Measured at Months 3 and 6 ]
  • 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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • 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
  • Experimental: Ondansetron followed by placebo
    Participants will take ondansetron then placebo plus an atypical antipsychotic drug
    Intervention: Drug: Ondansetron followed by placebo
  • Experimental: Placebo followed by Ondansetron
    Participants will take placebo then ondansetron plus an atypical antipsychotic drug
    Intervention: Drug: Placebo followed by Ondansetron

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
May 2010
May 2010   (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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00149734
04-0255
R01MH050787 ( U.S. NIH Grant/Contract )
COMIRB # 04-0255
DNBBS 73-MCR
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
Plan to Share IPD: No
University of Colorado, Denver
University of Colorado, Denver
National Institute of Mental Health (NIMH)
Principal Investigator: Lawrence E. Adler, MD University of Colorado Health Sciences Center, VISN19 MIRECC
University of Colorado, Denver
May 2017

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