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Switching Medication to Treat Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Risperidone
Olanzapine
Ziprasidone
Quetiapine
Aripiprazole
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Stay on baseline medication prescribed

    Switch per study protocol

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Number Who Discontinued Medication Within First 6 Study Months

    Secondary Outcome Measures

    Psychiatric Symptoms, Hospitalization, and Medication Side Effects

    Full Information

    First Posted
    September 3, 2002
    Last Updated
    March 28, 2016
    Sponsor
    Icahn School of Medicine at Mount Sinai
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00044655
    Brief Title
    Switching Medication to Treat Schizophrenia
    Official Title
    Effectiveness of Switching Antipsychotic Medications
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2001 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Icahn School of Medicine at Mount Sinai
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    219 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stay on baseline medication prescribed
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Switch per study protocol
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Risperidone
    Other Intervention Name(s)
    Risperdal, Risperdal Consta
    Intervention Description
    As prescribed by routine prescriber (not dictated by study protocol)
    Intervention Type
    Drug
    Intervention Name(s)
    Olanzapine
    Other Intervention Name(s)
    Zyprexa
    Intervention Description
    As prescribed by routine prescriber (not dictated by study protocol)
    Intervention Type
    Drug
    Intervention Name(s)
    Ziprasidone
    Other Intervention Name(s)
    Geodon
    Intervention Description
    As prescribed by routine prescriber (not dictated by study protocol)
    Intervention Type
    Drug
    Intervention Name(s)
    Quetiapine
    Other Intervention Name(s)
    Seroquel
    Intervention Description
    As prescribed by routine prescriber (not dictated by study protocol)
    Intervention Type
    Drug
    Intervention Name(s)
    Aripiprazole
    Other Intervention Name(s)
    Abilify
    Intervention Description
    As prescribed by routine prescriber (not dictated by study protocol)
    Primary Outcome Measure Information:
    Title
    Number Who Discontinued Medication Within First 6 Study Months
    Time Frame
    Measured at Six Months
    Secondary Outcome Measure Information:
    Title
    Psychiatric Symptoms, Hospitalization, and Medication Side Effects
    Time Frame
    Measured at Year 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susan M. Essock, PhD
    Organizational Affiliation
    Columbia University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22480442
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21536693
    Citation
    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.
    Results Reference
    result

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    Switching Medication to Treat Schizophrenia

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