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

Condition(s) targeted: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders

Intervention: Ramelteon (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
David C. Henderson, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Karina Tsatourian, Ph.D., Phone: 617-912-7800, Ext: 7882, Email: ktsatourian@partners.org

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.

Official title: Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study

Primary outcome: Reduction in waist circumference and abdominal fat (DEXA). Insulin resistance as measured by the homeostatic model assessment of insulin resistance (HOMA-IR).

Secondary outcome: Fasting triglycerides,increasing fasting HDL, and improving LDL-particle size Food intake and energy expenditure Inflammatory biomarkers Quality of sleep Tardive dyskinesia

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Karina Tsatourian, Ph.D., Phone: 617-912-7800, Ext: 7882, Email: ktsatourian@partners.org

Freedom Trail Clinic, Boston, Massachusetts 02114, United States; Recruiting
Karina Tsatourian, Ph.D., Phone: 617-912-7882, Email: ktsatourian@partners.org
David C. Henderson, M.D., Principal Investigator

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Starting date: January 2008
Ending date: June 2009
Last updated: February 9, 2009