Overview

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

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
Takeda