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Trial record 3 of 3 for:    9753305 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT00595504
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : September 13, 2012
Last Update Posted : September 13, 2012
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
David C. Henderson, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Interventions Drug: Ramelteon
Drug: Placebo
Enrollment 25

Recruitment Details 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 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.
Arm/Group Title Ramelteon Placebo
Hide Arm/Group Description [Not Specified] sugar pill
Period Title: Overall Study
Started 16 9
Completed 14 6
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             1             3
Physician Decision             1             0
Arm/Group Title Ramelteon Placebo Total
Hide Arm/Group Description [Not Specified] sugar pill Total of all reporting groups
Overall Number of Baseline Participants 14 6 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 6 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
6
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 6 participants 20 participants
49  (7) 56  (9) 53  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 6 participants 20 participants
Female
6
  42.9%
1
  16.7%
7
  35.0%
Male
8
  57.1%
5
  83.3%
13
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 6 participants 20 participants
14 6 20
1.Primary Outcome
Title Change in Waist Circumference
Hide Description A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis (intent to treat) were those that completed the study.
Arm/Group Title Ramelteon Placebo (Sugar Pill)
Hide Arm/Group Description:
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
Overall Number of Participants Analyzed 14 6
Mean (Standard Deviation)
Unit of Measure: cm
106.09  (8.8) 108.37  (6.5)
2.Primary Outcome
Title Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Hide Description A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis (intent to treat) were those that completed the study.
Arm/Group Title Ramelteon Placebo (Sugar Pill)
Hide Arm/Group Description:
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
Overall Number of Participants Analyzed 14 6
Mean (Standard Deviation)
Unit of Measure: HOMA score
2.4  (1.51) 2.36  (1.73)
3.Primary Outcome
Title Change in Abdominal Fat (DEXA).
Hide Description A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis (intent to treat) were those that completed the study.
Arm/Group Title Ramelteon Placebo (Sugar Pill)
Hide Arm/Group Description:
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
Overall Number of Participants Analyzed 14 6
Mean (Standard Deviation)
Unit of Measure: g
3934.86  (1151.97) 5120.92  (1770.58)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ramelteon Placebo
Hide Arm/Group Description [Not Specified] sugar pill
All-Cause Mortality
Ramelteon Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ramelteon Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ramelteon Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/9 (0.00%) 
The limitations of this study include the relatively small sample size and short intervention period (8 weeks).
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
Publications:
Ritz R CJ: Indirect Calorimetry. Monitoring in Respiratory Care. St Louis, MO, Mosby-Yearbook, Inc, 1993
Responsible Party: David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00595504     History of Changes
Other Study ID Numbers: 2007P-001929
FWA00003136
First Submitted: January 7, 2008
First Posted: January 16, 2008
Results First Submitted: April 26, 2012
Results First Posted: September 13, 2012
Last Update Posted: September 13, 2012