Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Massachusetts General Hospital Takeda Global Research & Development Center, Inc. |
---|---|
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00595504 |
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:
Condition | Intervention | Phase |
---|---|---|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorders |
Drug: Ramelteon Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia |
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Ramelteon
Ramelteon 8mg/day, or placebo shortly after the baseline assessment for 8 consecutive weeks.
|
2: Placebo Comparator |
Drug: Placebo
Ramelteon 8mg/day, or placebo shortly after the baseline assessment for 8 consecutive weeks.
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karina Tsatourian, Ph.D. | 617-912-7800 ext 7882 | ktsatourian@partners.org |
United States, Massachusetts | |
Freedom Trail Clinic | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Karina Tsatourian, Ph.D. 617-912-7882 ktsatourian@partners.org | |
Principal Investigator: David C. Henderson, M.D. |
Principal Investigator: | David C. Henderson, M.D. | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( David C. Henderson, M.D. ) |
Study ID Numbers: | 2007P-001929, FWA00003136 |
Study First Received: | January 7, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00595504 |
Health Authority: | United States: Food and Drug Administration |
schizophrenia metabolism antipsychotics diabetes rozerem |
Schizophrenia Mental Disorders Diabetes Mellitus Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Pathologic Processes Disease |