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

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 followed by placebo Drug: Placebo followed by Ondansetron


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Atypical Antipsychotics and P50 Sensory Gating

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

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 ]


Enrollment:	85
Study Start Date:	January 2005
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ondansetron followed by placebo Participants will take ondansetron then placebo plus an atypical antipsychotic drug	Drug: Ondansetron followed by placebo 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. Other Name: Zofran, Zuplenz
Experimental: Placebo followed by Ondansetron Participants will take placebo then ondansetron plus an atypical antipsychotic drug	Drug: Placebo followed by Ondansetron 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. Other Name: Zofran, Zuplenz

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

University of Colorado, Denver

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, Denver
ClinicalTrials.gov Identifier:	NCT00149734 History of Changes
Other Study ID Numbers:	04-0255 R01MH050787 COMIRB # 04-0255 DNBBS 73-MCR
Study First Received:	September 6, 2005
Last Updated:	August 5, 2015
Health Authority:	United States: Federal Government

Keywords provided by University of Colorado, Denver:


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

Additional relevant MeSH terms:


Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Antipsychotic Agents Ondansetron Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Antiemetics	Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents

ClinicalTrials.gov processed this record on September 23, 2016