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Study 9 of 2431 for search of: | received on or after 11/14/2008 |
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Brief Title † | Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia | ||||||||||||
Official Title † | Comparison of Optimal Antipsychotic Treatments for Schizophrenia Pilot Study | ||||||||||||
Brief Summary | This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of other medications to limit treatment side effects, in adults with schizophrenia. |
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Detailed Description | Schizophrenia is a chronic brain disease affecting approximately 1% of Americans. Antipsychotic medications can treat some of the most severe symptoms of schizophrenia, but they are not a cure, are often taken for long periods of time, and can have severe side effects. Other, secondary medications can provide relief from some of the most common severe side effects. This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of additional medications to limit treatment side effects, in adults with schizophrenia. Participation in this study will last 28 to 30 weeks and include 11 visits to a study clinic. Each visit will last 2 to 3 hours. The first 2 visits will include screening and baseline measurements. The screening visit will take place at study entry, and the baseline visit will take place 3 to 14 days later. Study visits will then occur 1, 2, and 4 weeks after the baseline visit, followed by monthly visits. At the baseline visit participants will be randomly assigned to receive olanzapine, perphenazine, or aripiprazole for 28 weeks. Dosage for all three antipsychotic medications will start at low levels and be increased to full strength over 2 weeks. If participants are taking another antipsychotic when they enter the study, this 2-week period will also be used to slowly reduce and then end treatment with the non-study antipsychotic. Side effects to all three antipsychotics will be monitored, and, depending on the side effect, one of three different medications will be added to the treatment regimen. If increased cholesterol levels are experienced with any antipsychotic, simvastatin will be added; if weight gain is experienced, metformin will be added; if involuntary movements, inner restlessness, or muscle stiffness are experienced, benztropine will be added. Because of already known side effects, participants assigned to olanzapine or perphenazine will automatically add metformin or benztropine, respectively, to their regimens. Starting on the third study visit, participants will also undergo a behavioral treatment aimed at reducing cardiovascular risk factors. This behavioral treatment will involve nine 20-minute sessions, with phone calls being made to participants between sessions. During each study visit, assessments will be made of schizophrenia symptoms, side effects, adherence to medication regimen, vital signs, waist circumference, and weight. Participants will also complete a questionnaire on use of health care services and undergo instructions on exercise and eating right. On visits 1, 5, 7, and 11, blood will be drawn for standard lab tests. Additional measures at the screening visit will include questions about medical and psychiatric history, a urine test for drugs, and a questionnaire about physical and social activities. |
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Study Phase | Phase IV | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||||||
Primary Outcome Measure † | Identification of appropriate clinical sites to mount the proposed clinical trial [ Time Frame: Measured pre- and post-treatment ] [ Designated as safety issue: No ] Feasibility of randomizing a cohort of participants meeting the inclusion and exclusion criteria of the study [ Time Frame: Measured pre- and post-treatment ] [ Designated as safety issue: No ] Feasibility of protocol implementation with a high level of protocol adherence and low participant attrition. The goal is for fewer than 25% of enrolled participants to be poorly adherent to the protocol interventions. [ Time Frame: Measured over 28 weeks of study visits ] [ Designated as safety issue: No ] |
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Secondary Outcome Measure † | Antipsychotic efficacy, defined as completion of the trial without psychiatric hospitalization, clinician decision to discontinue treatment, or patient decision to discontinue treatment [ Time Frame: Measured over 28 weeks of study visits ] [ Designated as safety issue: No ] | ||||||||||||
Condition † | Schizophrenia | ||||||||||||
Intervention † | Drug: Olanzapine Drug: Perphenazine Drug: Aripiprazole Behavioral: Behavioral Treatment Drug: Metformin Drug: Simvastatin Drug: Benztropine |
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Recruitment Information Fields | |||||||||||||
Recruitment Status † | Recruiting | ||||||||||||
Enrollment † | 60 | ||||||||||||
Start Date † | December 2008 | ||||||||||||
Completion Date | September 2009 | ||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | 18 Years to 40 Years | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† |
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Location Countries † | United States | ||||||||||||
Administrative Information Fields | |||||||||||||
NCT ID † | NCT00802100 | ||||||||||||
Organization ID | N01 MH090001-02 | ||||||||||||
Secondary IDs †† | N01MH90001, DSIR AT | ||||||||||||
Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||||||
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Information Provided By | National Institute of Mental Health (NIMH) | ||||||||||||
Verification Date | January 2009 | ||||||||||||
First Received Date † | December 3, 2008 | ||||||||||||
Last Updated Date | January 5, 2009 |