Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia

NCT00149734 | Completed Phase 3 Results FDA Drug

• 4 other identifiers: 04-0255R01MH050787COMIRB # 04-0255DNBBS 73-MCR
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Ondansetron; P50 sensory gating; Evoked potentials; 5-HT3 receptors; Atypical antipsychotics

Outcome Measures

Primary Outcomes (2)

• P50 Sensory Gating

  P50 Sensory Gating as measured by evoked potentials (response to stimuli, in this case, clicking sounds).The P50 potential was identified and measured using a computer algorithm. The amplitude of the P50 test wave was divided by the amplitude of the P50 conditioning wave, expressed as a percentage: the P50 ratio. Lower P50 ratios represent better outcomes.

  Up to 3 hours

• Cognitive Testing

  Measured at Months 3 and 6

Study Arms (2)

Ondansetron followed by placebo

EXPERIMENTAL

Participants will take ondansetron then placebo plus an atypical antipsychotic drug

Drug: Ondansetron followed by placebo

Placebo followed by Ondansetron

EXPERIMENTAL

Participants will take placebo then ondansetron plus an atypical antipsychotic drug

Drug: Placebo followed by Ondansetron

Interventions

Ondansetron followed by placebo DRUG

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.

Also known as: Zofran, Zuplenz

Ondansetron followed by placebo

Placebo followed by Ondansetron DRUG

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.

Also known as: Zofran, Zuplenz

Placebo followed by Ondansetron

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meets DSM-IV criteria for schizophrenia
• Stable, chronic schizophrenia
• Currently taking atypical medications
• Use of effective form of contraception throughout study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Denver VAMC

Denver, Colorado, 80220, United States

Location

Related Publications (2)

• 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. doi: 10.1176/appi.ajp.162.2.386.

  PMID: 15677607 BACKGROUND

• 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. doi: 10.1176/ajp.161.10.1822.

  PMID: 15465979 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

Limited data is available. The PI has left the university and has confirmed that he no longer has access to the data, and the remaining members of the study team confirmed that the data no longer exists. The study design was altered after registration due to a protocol amendment to not do a long-term study but to directly study participants on long-term clozapine treatment (a 5HT3 receptor antagonist like ondansetron) with other antipsychotics, including atypicals.

Results Point of Contact

• Title: Director, Clinical Research Administration
• Organization: University of Colorado Denver

clinicalresearchsupportcenter@ucdenver.edu

3037241111

Study Officials

• Lawrence E. Adler, MD

  University of Colorado Health Sciences Center, VISN19 MIRECC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: January 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 13, 2021
• Results First Posted: August 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)