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

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00595504
First received: January 7, 2008
Last updated: August 14, 2012
Last verified: August 2012

January 7, 2008
August 14, 2012
January 2008
March 2010   (final data collection date for primary outcome measure)
  • Change in Waist Circumference [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: Yes ]
    A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.
  • Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: Yes ]
    A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8.
  • Change in Abdominal Fat (DEXA). [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: Yes ]
    A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.
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 ]
Complete list of historical versions of study NCT00595504 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorders
  • Drug: 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.
    Other Name: Rozerem
  • 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.
  • Experimental: 1
    Ramelteon 8mg/day
    Intervention: Drug: Ramelteon
  • Placebo Comparator: 2
    sugar pill
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2010
March 2010   (final data collection date for primary outcome measure)

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:

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00595504
2007P-001929, FWA00003136
Yes
David C. Henderson, Massachusetts General Hospital
Massachusetts General Hospital
Takeda
Principal Investigator: David C. Henderson, M.D. Massachusetts General Hospital
Massachusetts General Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP