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Study 9 of 2431 for search of: | received on or after 11/14/2008 |
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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00802100 |
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.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Olanzapine Drug: Perphenazine Drug: Aripiprazole Behavioral: Behavioral Treatment Drug: Metformin Drug: Simvastatin Drug: Benztropine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Optimal Antipsychotic Treatments for Schizophrenia Pilot Study |
Estimated Enrollment: | 60 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Olanzapine: Experimental
Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
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Drug: Olanzapine
Daily tablets of 10 to 30 mg
Behavioral: Behavioral Treatment
Individualized behavioral treatment aimed at modifying weight and activity level
Drug: Metformin
Daily tablets of 850 to 2550 mg
Drug: Simvastatin
Daily tablets of 20 to 40 mg
Drug: Benztropine
Daily tablets of 1 to 2 mg
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Perphenazine: Experimental
Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
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Drug: Perphenazine
Daily tablets of 8 to 24 mg
Behavioral: Behavioral Treatment
Individualized behavioral treatment aimed at modifying weight and activity level
Drug: Metformin
Daily tablets of 850 to 2550 mg
Drug: Simvastatin
Daily tablets of 20 to 40 mg
Drug: Benztropine
Daily tablets of 1 to 2 mg
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Aripiprazole: Experimental
Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
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Drug: Aripiprazole
Daily tablets of 10 to 30 mg
Behavioral: Behavioral Treatment
Individualized behavioral treatment aimed at modifying weight and activity level
Drug: Metformin
Daily tablets of 850 to 2550 mg
Drug: Simvastatin
Daily tablets of 20 to 40 mg
Drug: Benztropine
Daily tablets of 1 to 2 mg
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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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contraindications to metformin use, including any of the following:
Contact: Ingrid A. Rojas, MPM | 919-843-7365 | irojas@med.unc.edu |
United States, California | |
SHANTI Clinical Trials | Not yet recruiting |
Colton, California, United States, 92324 | |
Contact: Satish Sood, PhD 909-423-0367 satishsood41@gmail.com | |
Principal Investigator: Gurmet S. Multani, MD | |
Stanford University | Not yet recruiting |
Palo Alto, California, United States, 94305 | |
Contact: Alexandra Bond 650-723-6678 alexbond@stanford.edu | |
Principal Investigator: Ira Glick, MD | |
United States, Connecticut | |
Yale University | Not yet recruiting |
New Haven, Connecticut, United States, 06519 | |
Contact: Maegan Krasenics 203-974-7544 maegan.krasenics@yale.edu | |
Principal Investigator: Cyril D'Souza, MD | |
United States, Florida | |
University of Miami School of Medicine | Recruiting |
Miami, Florida, United States, 33316 | |
Contact: Karina Fajardo, MD 305-355-8186 compstar@med.miami.edu | |
Principal Investigator: Richard Steinbook, MD | |
United States, Georgia | |
Medical College of Georgia | Not yet recruiting |
Augusta, Georgia, United States, 30912 | |
Contact: Edna Stirewalt 706-721-7968 estirewalt@mcg.edu | |
Principal Investigator: Peter F. Buckley, MD | |
United States, Maryland | |
Clinical Insights | Not yet recruiting |
Glen Burnie, Maryland, United States, 21061 | |
Contact: Lorri Cerro 410-768-2630 cerro@clinicalinsights.com | |
Principal Investigator: Lawrence Adler, MD | |
United States, Massachusetts | |
University of Massachusetts | Not yet recruiting |
Worcester, Massachusetts, United States, 01605 | |
Contact: Mara Novak 508-334-7352 Mara.Novak@umassmed.edu | |
Principal Investigator: Jayendra Patel, MD | |
United States, Michigan | |
Wayne State University | Not yet recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Vickie Wilson 313-745-3585 vwilson@med.wayne.edu | |
Principal Investigator: Rajaprabhakaran Rajarethinam, MD | |
United States, Minnesota | |
University of Minnesota School of Medicine | Not yet recruiting |
Minneapolis, Minnesota, United States, 55454 | |
Contact: Elizabeth Lemke 612-627-4840 lemke022@umn.edu | |
Principal Investigator: Stephen Olson, MD | |
United States, New York | |
Research Foundation for Mental Hygiene | Not yet recruiting |
New York, New York, United States, 10032 | |
Contact: Marlene Carlson, MPH 212-543-5678 mcarlson@pi.cpmc.columbia.edu | |
Principal Investigator: Jeffrey A. Lieberman, MD | |
United States, North Carolina | |
Duke University Medical Center-John Umstead Hospital | Recruiting |
Butner, North Carolina, United States, 27509 | |
Contact: Nancy McGrady 919-575-7213 nmcgrady@duke.edu | |
Principal Investigator: Joseph McEvoy, MD | |
United States, Texas | |
University of Texas Southwestern Medical Center | Not yet recruiting |
Dallas, Texas, United States, 75235 | |
Contact: Mark Bushong 214-648-4603 mark.bushong@UTshouthwestern.edu | |
Principal Investigator: Matthew Byerly, MD | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Jessica Eiseman 718-873-6136 eiseman@bcm.tmc.edu | |
Principal Investigator: Michael Barber, MD | |
United States, Wisconsin | |
Rogers Center for Research and Training, Inc | Not yet recruiting |
Milwaukee, Wisconsin, United States, 53227-1133 | |
Contact: Amy Perkins 414-328-3702 APerkins@rogershospital.org | |
Principal Investigator: Kambiz Pahlavan, MD |
Principal Investigator: | Marvin Swartz, MD | Duke University |
Principal Investigator: | T. Scott Stroup, MD, MPH | The University of North Carolina at Chapel Hill |
Principal Investigator: | Joseph P. McEvoy, MD | Duke University |
Responsible Party: | University of North Carolina at Chapel Hill ( T. Scott Stroup ) |
Study ID Numbers: | N01 MH090001-02, N01MH90001, DSIR AT |
Study First Received: | December 3, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00802100 |
Health Authority: | United States: Federal Government |
Schizoaffective Disorder |
Schizophrenia Dopamine Perphenazine Simvastatin Mental Disorders Metformin |
Olanzapine Psychotic Disorders Aripiprazole Serotonin Benztropine Schizophrenia and Disorders with Psychotic Features |
Dopamine Uptake Inhibitors Antimetabolites Parasympatholytics Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiemetics Antiparkinson Agents Cholinergic Agents Therapeutic Uses Tranquilizing Agents |
Antilipemic Agents Gastrointestinal Agents Central Nervous System Depressants Enzyme Inhibitors Dopamine Antagonists Anticholesteremic Agents Antipsychotic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents |