Switching Medication to Treat Schizophrenia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 3, 2002

Last Updated Date

September 18, 2008

Start Date ^ICMJE

July 2001

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00044655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Switching Medication to Treat Schizophrenia

Official Title ^ICMJE

Effectiveness of Switching Antipsychotic Medications

Brief Summary

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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Risperidone
Drug: Olanzapine
Drug: Ziprasidone
Drug: Quetiapine
Drug: Aripiprazole

Study Arms / Comparison Groups

Active Comparator: Participants will continue taking medication prescribed at study entry
Active Comparator: Participants will change medications from medication prescribed at study entry

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

May 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00044655

Responsible Party

Susan M. Essock, PhD/Director, Department of Mental Health Services and Policy Research, New York State Psychiatric Institute and Columbia University

Study ID Numbers ^ICMJE

R01 MH59312, DSIR AT-SP

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Susan M. Essock, PhD

Columbia University College of Physicians and Surgeons

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP