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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 25
Study Start Date: January 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ramelteon 8mg/day
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
Placebo Comparator: 2
sugar pill
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.

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595504

Locations
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Takeda
Investigators
Principal Investigator: David C. Henderson, M.D. Massachusetts General Hospital
  More Information

Publications:

Responsible Party: David C. Henderson, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00595504     History of Changes
Other Study ID Numbers: 2007P-001929, FWA00003136
Study First Received: January 7, 2008
Results First Received: April 26, 2012
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
schizophrenia
metabolism
antipsychotics
diabetes
rozerem

Additional relevant MeSH terms:
Disease
Psychotic Disorders
Schizophrenia
Mental Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 20, 2014