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Switching Medication to Treat Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00044655
Recruitment Status : Completed
First Posted : September 5, 2002
Results First Posted : December 5, 2013
Last Update Posted : April 28, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Risperidone Drug: Olanzapine Drug: Ziprasidone Drug: Quetiapine Drug: Aripiprazole Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Switching Antipsychotic Medications
Study Start Date : July 2001
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Risperidone
As prescribed by routine prescriber (not dictated by study protocol)
Other Name: Risperdal, Risperdal Consta

Drug: Olanzapine
As prescribed by routine prescriber (not dictated by study protocol)
Other Name: Zyprexa

Drug: Ziprasidone
As prescribed by routine prescriber (not dictated by study protocol)
Other Name: Geodon

Drug: Quetiapine
As prescribed by routine prescriber (not dictated by study protocol)
Other Name: Seroquel

Drug: Aripiprazole
As prescribed by routine prescriber (not dictated by study protocol)
Other Name: Abilify
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.
 Drug: Risperidone
As prescribed by routine prescriber (not dictated by study protocol)
Other Name: Risperdal, Risperdal Consta

Drug: Olanzapine
As prescribed by routine prescriber (not dictated by study protocol)
Other Name: Zyprexa

Drug: Ziprasidone
As prescribed by routine prescriber (not dictated by study protocol)
Other Name: Geodon

Drug: Quetiapine
As prescribed by routine prescriber (not dictated by study protocol)
Other Name: Seroquel

Drug: Aripiprazole
As prescribed by routine prescriber (not dictated by study protocol)
Other Name: Abilify


Outcome Measures
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Primary Outcome Measures :
  1. Number Who Discontinued Medication Within First 6 Study Months [ Time Frame: Measured at Six Months ]

Secondary Outcome Measures :
  1. Psychiatric Symptoms, Hospitalization, and Medication Side Effects [ Time Frame: Measured at Year 1 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044655


Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Investigators
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Study Chair: Susan M. Essock, PhD Columbia University
More Information
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Publications of Results:

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00044655    
Other Study ID Numbers: GCO 98-924
R01MH059312 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2002    Key Record Dates
Results First Posted: December 5, 2013
Last Update Posted: April 28, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Risperidone
Aripiprazole
Quetiapine Fumarate
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists