Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia
Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Ondansetron followed by placebo (Drug); Placebo followed by Ondansetron (Drug)
Sponsored by: University of Colorado, Denver
Official(s) and/or principal investigator(s):
Lawrence E. Adler, MD, Principal Investigator, Affiliation: University of Colorado Health Sciences Center, VISN19 MIRECC
This study will examine the effects of ondansetron on auditory nerve activity in people with
schizophrenia who are being treated with new antipsychotics.
Official title: Atypical Antipsychotics and P50 Sensory Gating
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
P50 sensory gating
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
Minimum age: 18 Years.
Maximum age: 55 Years.
- Meets DSM-IV criteria for schizophrenia
- Stable, chronic schizophrenia
- Currently taking atypical medications
- Use of effective form of contraception throughout study
- 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
Locations and Contacts
Denver VAMC, Denver, Colorado 80220, United States
Adler LE, Cawthra EM, Donovan KA, Harris JG, Nagamoto HT, Olincy A, Waldo MC. Improved p50 auditory gating with ondansetron in medicated schizophrenia patients. Am J Psychiatry. 2005 Feb;162(2):386-8.
Adler LE, Olincy A, Cawthra EM, McRae KA, Harris JG, Nagamoto HT, Waldo MC, Hall MH, Bowles A, Woodward L, Ross RG, Freedman R. Varied effects of atypical neuroleptics on P50 auditory gating in schizophrenia patients. Am J Psychiatry. 2004 Oct;161(10):1822-8.
Starting date: January 2005
Last updated: August 5, 2015