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| Descriptive Information Fields | |||||||||
| Brief Title † | Switching Medication to Treat Schizophrenia | ||||||||
| Official Title † | Effectiveness of Switching Antipsychotic Medications | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Time to medication discontinuation [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | Psychiatric symptoms, hospitalization, and medication side effects [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: Yes ] | ||||||||
| Condition † | Schizophrenia | ||||||||
| Intervention † | Drug: Risperidone Drug: Olanzapine Drug: Ziprasidone Drug: Quetiapine Drug: Aripiprazole |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 300 | ||||||||
| Start Date † | July 2001 | ||||||||
| Completion Date | May 2009 | ||||||||
| Eligibility Criteria † | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00044655 | ||||||||
| Organization ID | R01 MH59312 | ||||||||
| Secondary IDs †† | DSIR AT-SP | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | September 3, 2002 | ||||||||
| Last Updated Date | February 12, 2008 | ||||||||
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