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Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia
Official Title  Atypical Antipsychotics and P50 Sensory Gating
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.

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 Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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 ]
Secondary Outcome Measure 
Condition  Schizophrenia
Intervention  Drug: Ondansetron
Drug: Pill placebo
Drug: Atypical antipsychotic drug
MEDLINE PMIDs 15677607,   15465979
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  90
Start Date  January 2005
Completion Date May 2009
Eligibility 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
Gender Both
Ages 18 Years to 55 Years
Accepts Healthy Volunteers No
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    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00149734
Organization ID R01 MH50787
Secondary IDs †† COMIRB # 04-0255, DNBBS 73-MCR
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Lawrence E. Adler, MD     University of Colorado Health Sciences Center, VISN19 MIRECC    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date March 2008
First Received Date  September 6, 2005
Last Updated Date March 4, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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