Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status and phase

Completed
Phase 3

Conditions

Schizophrenia

Treatments

Drug: Placebo followed by Ondansetron
Drug: Ondansetron followed by placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00149734
DNBBS 73-MCR
COMIRB # 04-0255
R01MH050787 (U.S. NIH Grant/Contract)
04-0255

Details and patient eligibility

About

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

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

8 participants in 2 patient groups

Ondansetron followed by placebo
Experimental group
Description:
Participants will take ondansetron then placebo plus an atypical antipsychotic drug
Treatment:
Drug: Ondansetron followed by placebo
Placebo followed by Ondansetron
Experimental group
Description:
Participants will take placebo then ondansetron plus an atypical antipsychotic drug
Treatment:
Drug: Placebo followed by Ondansetron

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems