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Switching Medication to Treat Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00044655
First received: September 3, 2002
Last updated: March 28, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Schizophrenia
Drug: Risperidone
Drug: Olanzapine
Drug: Ziprasidone
Drug: Quetiapine
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Switching Antipsychotic Medications

Resource links provided by NLM:


Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Number Who Discontinued Medication Within First 6 Study Months [ Time Frame: Measured at Six Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychiatric Symptoms, Hospitalization, and Medication Side Effects [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: Yes ]

Enrollment: 219
Study Start Date: July 2001
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044655

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

Publications:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00044655     History of Changes
Other Study ID Numbers: GCO 98-924  R01MH059312 
Study First Received: September 3, 2002
Results First Received: September 27, 2013
Last Updated: March 28, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Ziprasidone
Antipsychotic Agents
Aripiprazole
Quetiapine Fumarate
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators

ClinicalTrials.gov processed this record on December 02, 2016