Switching Medication to Treat Schizophrenia

Icahn School of Medicine at Mount Sinai219 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

219

Conditions

Schizophrenia

Interventions

RisperidoneDRUG

As prescribed by routine prescriber (not dictated by study protocol)

OlanzapineDRUG

As prescribed by routine prescriber (not dictated by study protocol)

ZiprasidoneDRUG

As prescribed by routine prescriber (not dictated by study protocol)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number Who Discontinued Medication Within First 6 Study Months

Time frame: Measured at Six Months

Secondary Outcomes

Number of Participants Hospitalized

Number of participants hospitalized for psychiatric reasons

Time frame: during first 6 months

Data from ClinicalTrials.gov

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