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

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00595504
First received: January 7, 2008
Last updated: August 14, 2012
Last verified: August 2012
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Interventions: Drug: Ramelteon
Drug: Placebo

  Participant Flow
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Recruitment Details
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

Pre-Assignment Details
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.

Reporting Groups
  Description
Ramelteon No text entered.
Placebo sugar pill

Participant Flow:   Overall Study
    Ramelteon     Placebo  
STARTED     16     9  
COMPLETED     14     6  
NOT COMPLETED     2     3  
Withdrawal by Subject                 1                 3  
Physician Decision                 1                 0  



  Baseline Characteristics
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Population Description
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.

Reporting Groups
  Description
Ramelteon No text entered.
Placebo sugar pill
Total Total of all reporting groups

Baseline Measures
    Ramelteon     Placebo     Total  
Number of Participants  
[units: participants]
  14     6     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     6     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  49  ± 7     56  ± 9     53  ± 8  
Gender  
[units: participants]
     
Female     6     1     7  
Male     8     5     13  
Region of Enrollment  
[units: participants]
     
United States     14     6     20  



  Outcome Measures
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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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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).


  More Information
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Certain Agreements:  
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
phone: 617-912-7800
e-mail: dchenderson@partners.org


Publications:


Responsible Party: David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00595504     History of Changes
Other Study ID Numbers: 2007P-001929, FWA00003136
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