CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8 enrolled
Drug / intervention
Ondansetron followed by placebo +1 moredrug
Likely dose
Ondansetron 16 mg daily for 3 months, or placebo for 3 months, followed by the opposite; plus atypical antipsychotic (olanzapine, quetiapine, or aripiprazole) throughout 6 monthsAI-extracted
Key inclusion· 3
  • ✓Meets DSM-IV criteria for schizophrenia
  • ✓Stable, chronic schizophrenia
  • ✓Currently taking atypical medications
Key exclusion· 6
  • ✕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

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00149734
NCT00149734Phase 3Completed
CompareCT.gov

Atypical Antipsychotics and P50 Sensory Gating

University of Colorado, Denver·interventional·Posted Sep 8, 2005·Updated Aug 13, 2021

In Brief

A Phase 3 clinical trial evaluating Ondansetron followed by placebo and Placebo followed by Ondansetron for Schizophrenia. Completed, enrolled 8 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartJan 1, 2005
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.8 years ago

Interventions

Ondansetron followed by placebodrug

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.

Placebo followed by Ondansetrondrug

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.