Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
This study has been completed.
Massachusetts General Hospital
Information provided by (Responsible Party):
David C. Henderson, Massachusetts General Hospital
First received: January 7, 2008
Last updated: August 14, 2012
Last verified: August 2012
Results First Received: April 26, 2012
|Study Design:||Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
|Subjects were recruited from the Freedom Trial Clinic at the Erich Lindemann Mental Health Center and were studied at the Mallinckrodt General Clinical Research Center (GCRC) at the Massachusetts General Hospital (MGH), Boston|
|Significant events and approaches for the overall study following participant enrollment, but prior to group assignment|
|After providing written informed consent, subjects underwent a diagnostic evaluation by a research psychiatrist using the Structured Clinical Interview for DSM-IV (SCID). All subjects were screened and enrolled based on eligibility criteria. Baseline study assessments were completed prior to intervention.|
|Ramelteon||No text entered.|
Participant Flow: Overall Study
|Withdrawal by Subject||1||3|
|Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.|
|No text entered.|
|Ramelteon||No text entered.|
|Total||Total of all reporting groups|
Overall Participants Analyzed
|Between 18 and 65 years||14||6||20|
Mean (Standard Deviation)
|49 (7)||56 (9)||53 (8)|
Region of Enrollment
|1. Primary:||Change in Waist Circumference [ Time Frame: Baseline and Week 8 ]|
|2. Primary:||Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). [ Time Frame: Baseline and Week 8 ]|
|3. Primary:||Change in Abdominal Fat (DEXA). [ Time Frame: Baseline and Week 8 ]|
Limitations and Caveats
|Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data|
|The limitations of this study include the relatively small sample size and short intervention period (8 weeks).|
Results Point of Contact:
|All Principal Investigators ARE employed by the organization sponsoring the study.|
Results Point of Contact:
Name/Title: David C. Henderson, M.D.
Organization: Massachusetts General Hospital
Organization: Massachusetts General Hospital
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|Responsible Party:||David C. Henderson, Massachusetts General Hospital|
|ClinicalTrials.gov Identifier:||NCT00595504 History of Changes|
|Other Study ID Numbers:||
|Study First Received:||January 7, 2008|
|Results First Received:||April 26, 2012|
|Last Updated:||August 14, 2012|
|Health Authority:||United States: Food and Drug Administration