Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00149734

Purpose

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

Condition	Intervention
Schizophrenia	Drug: Ondansetron Drug: Pill placebo Drug: Atypical antipsychotic drug

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Atypical Antipsychotics and P50 Sensory Gating

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

P50 sensory gating [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
Cognitive testing [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	January 2005
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will take ondansetron then placebo plus an atypical antipsychotic drug	Drug: Ondansetron Participants will take 16 mg of ondansetron daily for either the first or second 3 months of the medication treatment period. Drug: Pill placebo Participants will take the pill placebo for either the first or second 3 months of medication treatment. The placebo pill will be administered in the same fashion as the active ondansetron pills. Drug: Atypical antipsychotic drug All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole.
2: Experimental Participants will take placebo then ondansetron plus an atypical antipsychotic drug	Drug: Pill placebo Participants will take the pill placebo for either the first or second 3 months of medication treatment. The placebo pill will be administered in the same fashion as the active ondansetron pills. Drug: Atypical antipsychotic drug All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole.

Arms

Assigned Interventions

1: Experimental

Participants will take ondansetron then placebo plus an atypical antipsychotic drug

Drug: Ondansetron

Participants will take 16 mg of ondansetron daily for either the first or second 3 months of the medication treatment period.

Drug: Pill placebo

Participants will take the pill placebo for either the first or second 3 months of medication treatment. The placebo pill will be administered in the same fashion as the active ondansetron pills.

Drug: Atypical antipsychotic drug

All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole.

2: Experimental

Participants will take placebo then ondansetron plus an atypical antipsychotic drug

Drug: Pill placebo

Participants will take the pill placebo for either the first or second 3 months of medication treatment. The placebo pill will be administered in the same fashion as the active ondansetron pills.

Drug: Atypical antipsychotic drug

All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149734

Contacts

Contact: Merilyne C. Waldo, PhD	303-399-8020 ext 2404	merilyne.waldo@va.gov
Contact: Laurie Woodward, BS	303-393-5075	Laurie.Woodward@med.va.gov

Locations

United States, Colorado
Denver VAMC	Recruiting
Denver, Colorado, United States, 80220

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Lawrence E. Adler, MD

University of Colorado Health Sciences Center, VISN19 MIRECC

More Information

Publications:

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.

Responsible Party:	University of Colorado Health Sciences Center, Denver CO ( Lawrence Adler, MD )
Study ID Numbers:	R01 MH50787, COMIRB # 04-0255, DNBBS 73-MCR
Study First Received:	September 6, 2005
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00149734 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Schizophrenia
Ondansetron
P50 sensory gating

Evoked potentials
5-HT3 receptors
Atypical antipsychotics

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia
Serotonin Antagonists

Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Antipruritics
Anti-Anxiety Agents
Peripheral Nervous System Agents
Ondansetron
Dermatologic Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 04, 2010