Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
219 participants
INTERVENTIONAL
2001-07-31
2009-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Risperidone
As prescribed by routine prescriber (not dictated by study protocol)
Olanzapine
As prescribed by routine prescriber (not dictated by study protocol)
Ziprasidone
As prescribed by routine prescriber (not dictated by study protocol)
Quetiapine
As prescribed by routine prescriber (not dictated by study protocol)
Aripiprazole
As prescribed by routine prescriber (not dictated by study protocol)
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.
Risperidone
As prescribed by routine prescriber (not dictated by study protocol)
Olanzapine
As prescribed by routine prescriber (not dictated by study protocol)
Ziprasidone
As prescribed by routine prescriber (not dictated by study protocol)
Quetiapine
As prescribed by routine prescriber (not dictated by study protocol)
Aripiprazole
As prescribed by routine prescriber (not dictated by study protocol)
Interventions
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Risperidone
As prescribed by routine prescriber (not dictated by study protocol)
Olanzapine
As prescribed by routine prescriber (not dictated by study protocol)
Ziprasidone
As prescribed by routine prescriber (not dictated by study protocol)
Quetiapine
As prescribed by routine prescriber (not dictated by study protocol)
Aripiprazole
As prescribed by routine prescriber (not dictated by study protocol)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Susan M. Essock, PhD
Role: STUDY_CHAIR
Columbia University
References
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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.
Other Identifiers
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GCO 98-924
Identifier Type: -
Identifier Source: org_study_id
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