Switching Medication to Treat Schizophrenia - Full Text View

Purpose

This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: Risperidone Drug: Olanzapine Drug: Ziprasidone Drug: Quetiapine Drug: Aripiprazole	Phase IV

MedlinePlus related topics:

Mental Health Schizophrenia

ChemIDplus related topics:

Risperidone Quetiapine Quetiapine fumarate Olanzapine Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:	Effectiveness of Switching Antipsychotic Medications

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

Primary Outcome Measures:

Time to medication discontinuation [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Psychiatric symptoms, hospitalization, and medication side effects [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	July 2001
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stay: Active Comparator Participants will continue taking medication prescribed at study entry	Drug: Risperidone As prescribed by routine prescriber (not dictated by study protocol) Drug: Olanzapine As prescribed by routine prescriber (not dictated by study protocol) Drug: Ziprasidone As prescribed by routine prescriber (not dictated by study protocol) Drug: Quetiapine As prescribed by routine prescriber (not dictated by study protocol) Drug: Aripiprazole As prescribed by routine prescriber (not dictated by study protocol)
Switch: Active Comparator Participants will change medications from medication prescribed at study entry	Drug: Risperidone As prescribed by routine prescriber (not dictated by study protocol) Drug: Olanzapine As prescribed by routine prescriber (not dictated by study protocol) Drug: Ziprasidone As prescribed by routine prescriber (not dictated by study protocol) Drug: Quetiapine As prescribed by routine prescriber (not dictated by study protocol) Drug: Aripiprazole As prescribed by routine prescriber (not dictated by study protocol)

Detailed Description:

Over the past several years, new, "atypical" antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients.

Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or aripiprazole. Participants currently taking a single conventional injectable will begin taking long-acting injectable risperidone (Risperdal Consta). Participants currently taking two antipsychotic medications will begin taking only one of the medications they are currently using. Participants will stay on their assigned treatment for 6 months, after which time the participant's prescribing psychiatrist will advise the participant on which medication should be used. Study participants are interviewed at study start and at follow-up visits for 1 year.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

SCID diagnosis of schizophrenia or schizoaffective disorder
Partially remitted outpatients, defined as persons who have received clear symptomatic benefit from antipsychotic medication but remain symptomatic (due to lack of efficacy or inability to tolerate an efficacious dose) or suffer significant side effects
Treatment with antipsychotic medications for at least 2 months
Received at least 1 outpatient mental health service every 3 months for the past 6 months

Exclusion criteria:

Severe symptoms or side effects that indicate the necessity for a medication change
Currently taking 3 or more antipsychotic medications for ongoing daily administration (PRN medications and mood stabilizers are allowable)
Treatment with clozapine
One or more nights spent in a psychiatric hospitalization within the past 3 months
Received services from a crisis intervention program within the past 3 months
Require placement in a skilled nursing facility as a result of a physical condition or disability
Criminal charges pending (once charges clear, the person will be considered)
Pregnant or breast feeding
Contraindication to any of the medications to which the patient might be assigned

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044655

Contacts


Contact: Susan M. Essock, PhD	212-543-6629	se2176@columbia.edu

Contact: Nancy H. Covell, PhD	860-418-6655	nancy.covell@po.state.ct.us

Locations


United States, Connecticut
	State of Connecticut Department of Mental Health and Addiction Services Outpatient Mental Health Centers	Completed
	Hartford, Connecticut, United States, 06134
	Yale University School of Medicine	Active, not recruiting
	New Haven, Connecticut, United States, 06519

United States, Florida
	Mental Health Advocates, Inc.	Active, not recruiting
	Boca Raton, Florida, United States, 33432
	University of Miami	Recruiting
	Miami, Florida, United States, 33136
	Contact: Richard M. Steinbrook, MD 305-355-8260
	Contact: Marvin I. Herz, MD 305-355-8260

United States, Maryland
	Clinical Insights	Recruiting
	Glen Burnie, Maryland, United States, 21061
	Contact: Lawrence W. Adler, MD 410-768-2629

United States, Massachusetts
	University of Massachusetts Medical School	Recruiting
	Worcester, Massachusetts, United States, 01605
	Contact: Chelsea Wogsland 508-856-5312
	Dr. John C. Corrigan Community Mental Health Center	Recruiting
	Fall River, Massachusetts, United States, 02720
	Contact: Meredith Hanrahan-Boshes 508-235-7290

United States, Minnesota
	University of Minnesota	Recruiting
	Minneapolis, Minnesota, United States, 55454
	Contact: Elizabeth Lemke, MA 612-627-4840
	Contact: Steve Olson, MD 612-627-4364

United States, Missouri
	Washington University School of Medicine	Active, not recruiting
	St. Louis, Missouri, United States, 63110

United States, New York
	Bronx VA Medical Center	Active, not recruiting
	Bronx, New York, United States, 10468

United States, North Carolina
	John Umstead Hospital	Recruiting
	Butner, North Carolina, United States, 27509
	Contact: William H. Wilson, PhD 919-575-7360

United States, Ohio
	University of Cincinnati Medical Center	Active, not recruiting
	Cincinnati, Ohio, United States, 45267

United States, Pennsylvania
	VA Medical Center, University of Pennsylvania	Recruiting
	Philadelphia, Pennsylvania, United States, 19104
	Contact: Christine Beswick 215-823-4065
	Contact: Stanley Caroff, MD 215-823-4066

United States, Texas
	University of Texas Southwestern Medical Center at Dallas	Recruiting
	Dallas, Texas, United States, 75235
	Contact: Matthew Byerly, MD 214-648-5290
	University of Texas Health Science Center at San Antonio	Recruiting
	San Antonio, Texas, United States, 78229
	Contact: Desiree Castillo 210-567-0781

United States, Washington
	VA Puget Sound Health Care System	Recruiting
	Tacoma, Washington, United States, 98493
	Contact: Annette Kennedy 253-583-1671

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Study Chair:	Susan M. Essock, PhD	Columbia University College of Physicians and Surgeons

More Information

Responsible Party:	New York State Psychiatric Institute and Columbia University ( Susan M. Essock, PhD/Director, Department of Mental Health Services and Policy Research )
Study ID Numbers:	R01 MH59312, DSIR AT-SP
First Received:	September 3, 2002
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00044655
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Schizophrenia

Quetiapine

Dopamine

Mental Disorders

Risperidone

Olanzapine

Psychotic Disorders

Aripiprazole

Ziprasidone

Serotonin

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Psychotropic Drugs

Antiemetics

Central Nervous System Depressants

Dopamine Antagonists

Antipsychotic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Antagonists

Serotonin Agents

Autonomic Agents

Therapeutic Uses

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00044655