Switching Medication to Treat Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Switching Antipsychotic Medications

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Risperidone
* Drug: Olanzapine
* Drug: Ziprasidone
* Drug: Quetiapine
* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stay on baseline medication prescribed<br>Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications. | Drug: Risperidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Risperdal, Risperdal Consta;Drug: Olanzapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Zyprexa;Drug: Ziprasidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Geodon;Drug: Quetiapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Seroquel;Drug: Aripiprazole<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Abilify;|
| Active Comparator: Switch per study protocol<br>Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications. | Drug: Risperidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Risperdal, Risperdal Consta;Drug: Olanzapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Zyprexa;Drug: Ziprasidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Geodon;Drug: Quetiapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Seroquel;Drug: Aripiprazole<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Abilify;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Who Discontinued Medication Within First 6 Study Months |  | Measured at Six Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric Symptoms, Hospitalization, and Medication Side Effects |  | Measured at Year 1 |