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Switching Medication to Treat Schizophrenia
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00044655
  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
Drug Information available for: 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

Locations
United States, Connecticut
State of Connecticut Department of Mental Health and Addiction Services Outpatient Mental Health Centers
Hartford, Connecticut, United States, 06134
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
Mental Health Advocates, Inc.
Boca Raton, Florida, United States, 33432
University of Miami
Miami, Florida, United States, 33136
United States, Maryland
Clinical Insights
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605
Dr. John C. Corrigan Community Mental Health Center
Fall River, Massachusetts, United States, 02720
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Bronx VA Medical Center
Bronx, New York, United States, 10468
United States, North Carolina
John Umstead Hospital
Butner, North Carolina, United States, 27509
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
VA Medical Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
VA Puget Sound Health Care System
Tacoma, Washington, United States, 98493
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
Study First Received: September 3, 2002
Last Updated: September 18, 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 January 16, 2009



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