Phase 4 N=25 Randomized Quadruple-blind Treatment

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

Schizophrenia · Schizoaffective Disorder · Schizophreniform Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00595504 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Change in Waist Circumference — 106.09; 108.37 cm

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ramelteon (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Waist Circumference	106.09; 108.37	—
PRIMARY Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).	2.4; 2.36	—
PRIMARY Change in Abdominal Fat (DEXA).	3934.86; 5120.92	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00595504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.