Olanzapine Disintegrating Tablets |
Zyprexa Zydis Injection |
Clinical Trial: Switching Medication to Treat Schizophrenia
This study is currently recruiting patients.
|
Purpose
The purpose of this study is to determine whether people with schizophrenia who are relatively stable on their medications but still have symptoms or medication side effects should switch to atypical antipsychotic medication.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: Risperidone Drug: Olanzapine Drug: Ziprasidone Drug: Quetiapine Drug: Aripiprazole | Phase IV |
MedlinePlus related topics: Schizophrenia
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Effectiveness of Switching: Conventionals to Atypicals
Expected Total Enrollment: 300
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 are randomly assigned to receive olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify) or to remain on their current conventional antipsychotic medications. Participants stay on their assigned treatment for 6 months, after which time medication decisions will be made by the patient and the prescribing psychiatrist. Study participants are interviewed at study start and at follow-up visits for 1 year.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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 Medicaid 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 DMHAS crisis intervention program within the past 6 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
Location and Contact Information
Nancy H. Covell, PhD 860-418-6655 nancy.covell@po.state.ct.us
New York
Mount Sinai School of Medicine, New York, New York, 10029, United States; Recruiting
More Information
Record last reviewed: February 2005
Last Updated: February 17, 2005
Record first received: September 3, 2002
ClinicalTrials.gov Identifier: NCT00044655
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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