Switching Medication to Treat Schizophrenia

Mount Sinai Health System

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole; Drug: Olanzapine; Drug: Risperidone; Drug: Quetiapine; Drug: Ziprasidone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00044655

R01MH059312 (U.S. NIH Grant/Contract)

GCO 98-924

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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219 participants in 2 patient groups

Stay on baseline medication prescribed

Active Comparator group

Description:

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.

Treatment:

Drug: Ziprasidone

Drug: Quetiapine

Drug: Risperidone

Drug: Olanzapine

Drug: Aripiprazole

Switch per study protocol

Active Comparator group

Description:

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.

Treatment:

Drug: Ziprasidone

Drug: Quetiapine

Drug: Risperidone

Drug: Olanzapine

Drug: Aripiprazole