Switching Medication to Treat Schizophrenia

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.

Full Title of Study: “Effectiveness of Switching Antipsychotic Medications”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2009

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.

Interventions

  • Drug: Risperidone
    • As prescribed by routine prescriber (not dictated by study protocol)
  • Drug: Olanzapine
    • As prescribed by routine prescriber (not dictated by study protocol)
  • Drug: Ziprasidone
    • As prescribed by routine prescriber (not dictated by study protocol)
  • Drug: Quetiapine
    • As prescribed by routine prescriber (not dictated by study protocol)
  • Drug: Aripiprazole
    • As prescribed by routine prescriber (not dictated by study protocol)

Arms, Groups and Cohorts

  • Active Comparator: Stay on baseline medication prescribed
    • 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.
  • Active Comparator: Switch per study protocol
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number Who Discontinued Medication Within First 6 Study Months
    • Time Frame: Measured at Six Months

Secondary Measures

  • Psychiatric Symptoms, Hospitalization, and Medication Side Effects
    • Time Frame: Measured at Year 1

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Icahn School of Medicine at Mount Sinai
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Susan M. Essock, PhD, Study Chair, Columbia University

Citations Reporting on Results

Covell NH, McEvoy JP, Schooler NR, Stroup TS, Jackson CT, Rojas IA, Essock SM; Schizophrenia Trials Network. Effectiveness of switching from long-acting injectable fluphenazine or haloperidol decanoate to long-acting injectable risperidone microspheres: an open-label, randomized controlled trial. J Clin Psychiatry. 2012 May;73(5):669-75. doi: 10.4088/JCP.11m07074. Epub 2012 Mar 6.

Essock SM, Schooler NR, Stroup TS, McEvoy JP, Rojas I, Jackson C, Covell NH; Schizophrenia Trials Network. Effectiveness of switching from antipsychotic polypharmacy to monotherapy. Am J Psychiatry. 2011 Jul;168(7):702-8. doi: 10.1176/appi.ajp.2011.10060908. Epub 2011 May 2.

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