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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ramelteon
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, metabolism, antipsychotics, diabetes, rozerem

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Freedom Trail Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Ramelteon 8mg/day

sugar pill

Outcomes

Primary Outcome Measures

Change in Waist Circumference
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).
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).
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.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2008
Last Updated
August 14, 2012
Sponsor
Massachusetts General Hospital
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00595504
Brief Title
Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
Official Title
Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
Keywords
schizophrenia, metabolism, antipsychotics, diabetes, rozerem

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Ramelteon 8mg/day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
sugar pill
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Other Intervention Name(s)
Rozerem
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Waist Circumference
Description
A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.
Time Frame
Baseline and Week 8
Title
Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Description
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.
Time Frame
Baseline and Week 8
Title
Change in Abdominal Fat (DEXA).
Description
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.
Time Frame
Baseline and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Henderson, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freedom Trail Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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

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