Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	Takeda Global Research & Development Center, Inc.
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00595504

Sponsor:

Massachusetts General Hospital

Collaborator:

Takeda Global Research & Development Center, Inc.

Information provided by:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00595504

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorders	Drug: Ramelteon Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Ramelteon

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Reduction in waist circumference and abdominal fat (DEXA). Insulin resistance as measured by the homeostatic model assessment of insulin resistance (HOMA-IR). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Fasting triglycerides,increasing fasting HDL, and improving LDL-particle size Food intake and energy expenditure Inflammatory biomarkers Quality of sleep Tardive dyskinesia [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Ramelteon Ramelteon 8mg/day, or placebo shortly after the baseline assessment for 8 consecutive weeks.
2: Placebo Comparator	Drug: Placebo Ramelteon 8mg/day, or placebo shortly after the baseline assessment for 8 consecutive weeks.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
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 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

Responsible Party:	Massachusetts General Hospital ( David C. Henderson, M.D. )
Study ID Numbers:	2007P-001929, FWA00003136
Study First Received:	January 7, 2008
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00595504 History of Changes
Health Authority:	United States: Food and Drug Administration

United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114