Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
NCT ID: NCT00595504
Last Updated: 2012-09-13
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-01-31
Study Completion Date
2010-03-31
Brief Summary
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This study involves people who have schizophrenia or schizoaffective disorder who are currently taking antipsychotic medications. Some antipsychotic medications may cause weight gain and may increase the risk of diabetes mellitus and heart disease.The purpose of this study is to find out what happens if another medication (ramelteon) is used along with your antipsychotic medication. We want to find out whether doing this will:
* Change the way your body breaks down fat and sugar.
* Affect your waist size, stomach fat and triglycerides (a type of fat in your blood).
* Improve how your body responds to insulin.
* Affect your quality of sleep.
* Reduce movement disturbances Ramelteon is approved by the U.S. Food and Drug Administration (FDA) to treat people that have difficulty falling asleep. It is not approved for such things as affecting waist size or improving how the body breaks down fat and sugar. Its use in this study is investigational.
* Change the way your body breaks down fat and sugar.
* Affect your waist size, stomach fat and triglycerides (a type of fat in your blood).
* Improve how your body responds to insulin.
* Affect your quality of sleep.
* Reduce movement disturbances Ramelteon is approved by the U.S. Food and Drug Administration (FDA) to treat people that have difficulty falling asleep. It is not approved for such things as affecting waist size or improving how the body breaks down fat and sugar. Its use in this study is investigational.
Detailed Description
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This is an 8-week randomized, double blind, placebo-controlled pilot study with 4- week follow up assessment, of ramelteon 8 mg/day, administered to subjects for 8 consecutive weeks as an adjunctive therapy in 40 non-diabetic schizophrenia subjects to examine ramelteon effects on body composition, glucose and lipid metabolism, sleep quality and symptoms of tardive dyskinesia using the Massachusetts General Hospital General Clinical Research Center. As far as we know, no previous study has been done to explore the potential role of ramelteon in improving metabolic, sleep, and movement disturbances in schizophrenia subjects. The novel approach of adjunctive ramelteon treatment in the schizophrenia population is promising.
Conditions
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Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Keywords
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schizophrenia
metabolism
antipsychotics
diabetes
rozerem
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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1
Ramelteon 8mg/day
Group Type
EXPERIMENTAL
Ramelteon
Intervention Type
DRUG
Two week supply of ramelteon 8mg/day first dispensed at baseline. New two week supply of study medication dispensed at each biweekly visit for 8 consecutive weeks.
2
sugar pill
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Two week supply of placebo tablets first dispensed at baseline. New two week supply of placebo dispensed at each biweekly visit for 8 consecutive weeks.
Interventions
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Ramelteon
Two week supply of ramelteon 8mg/day first dispensed at baseline. New two week supply of study medication dispensed at each biweekly visit for 8 consecutive weeks.
Intervention Type
DRUG
Placebo
Two week supply of placebo tablets first dispensed at baseline. New two week supply of placebo dispensed at each biweekly visit for 8 consecutive weeks.
Intervention Type
DRUG
Other Intervention Names
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Rozerem
Eligibility Criteria
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Inclusion Criteria
* diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder
* male or female, age 18-65 years
* treatment with clozapine, olanzapine, quetiapine or risperidone
* well established compliance with medications
* Body Mass Index (BMI) of \> 27 Kg/m² with any component of metabolic syndrome or insulin resistance or a BMI of \> 30 Kg/m²:
* male or female, age 18-65 years
* treatment with clozapine, olanzapine, quetiapine or risperidone
* well established compliance with medications
* Body Mass Index (BMI) of \> 27 Kg/m² with any component of metabolic syndrome or insulin resistance or a BMI of \> 30 Kg/m²:
Exclusion Criteria
* inability to provide informed consent
* substance and alcohol abuse
* significant medical illness, including congestive heart failure, severe hepatic impairment, severe Chronic Obstructive Pulmonary Disease (COPD), severe sleep apnea, severe cardiovascular disease or renal disease
* current history of diabetes mellitus or thyroid disease
* women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
* psychiatrically unstable, patients with major depression
* patients treated with medications known to affect glucose tolerance such as birth control pills containing norgestrel, steroids, beta blockers, anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; and agents that induce weight loss will be excluded from the study
* treatment with fluvoxamine in the or ketoconazole past two weeks
* treatment with fluconazole (a strong CYP2C9 inhibitor).
* subjects treated with ziprasidone and aripiprazole conventional agents
* treatment with sedative-hypnotics such as barbiturates, zolpidem, eszopiclone, zaleplon. The use of stable daily doses of benzodiazepines is allowed.
* known hypersensitivity to ramelteon or any of its components
* substance and alcohol abuse
* significant medical illness, including congestive heart failure, severe hepatic impairment, severe Chronic Obstructive Pulmonary Disease (COPD), severe sleep apnea, severe cardiovascular disease or renal disease
* current history of diabetes mellitus or thyroid disease
* women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
* psychiatrically unstable, patients with major depression
* patients treated with medications known to affect glucose tolerance such as birth control pills containing norgestrel, steroids, beta blockers, anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; and agents that induce weight loss will be excluded from the study
* treatment with fluvoxamine in the or ketoconazole past two weeks
* treatment with fluconazole (a strong CYP2C9 inhibitor).
* subjects treated with ziprasidone and aripiprazole conventional agents
* treatment with sedative-hypnotics such as barbiturates, zolpidem, eszopiclone, zaleplon. The use of stable daily doses of benzodiazepines is allowed.
* known hypersensitivity to ramelteon or any of its components
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Takeda
INDUSTRY
Sponsor Role
collaborator
Massachusetts General Hospital
OTHER
Sponsor Role
lead
Responsible Party
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David C. Henderson
Associate Professor of Psychiatry
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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David C. Henderson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Freedom Trail Clinic
Boston, Massachusetts, United States
Site Status
Countries
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United States
References
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Other Identifiers
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FWA00003136
Identifier Type: -
Identifier Source: secondary_id
2007P-001929
Identifier Type: -
Identifier Source: org_study_id