Phase 3 N=8 Randomized Quadruple-blind Treatment

Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00149734 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2021

Primary outcome: Primary: P50 Sensory Gating — 41.4; 80.2 percentage

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ondansetron followed by placebo (Drug); Placebo followed by Ondansetron (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY P50 Sensory Gating	41.4; 80.2	—
PRIMARY Cognitive Testing	—	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00149734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.