Trial Outcomes & Findings for Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia (NCT NCT00595504)
NCT ID: NCT00595504
Last Updated: 2012-09-13
Results Overview
A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.
COMPLETED
PHASE4
25 participants
Baseline and Week 8
2012-09-13
Participant Flow
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
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.
Participant milestones
| Measure |
Ramelteon
|
Placebo
sugar pill
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
9
|
|
Overall Study
COMPLETED
|
14
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Ramelteon
|
Placebo
sugar pill
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Ramelteon
n=14 Participants
|
Placebo
n=6 Participants
sugar pill
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
49 years
STANDARD_DEVIATION 7 • n=5 Participants
|
56 years
STANDARD_DEVIATION 9 • n=7 Participants
|
53 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
6 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: The number of participants for analysis (intent to treat) were those that completed the study.
A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.
Outcome measures
| Measure |
Ramelteon
n=14 Participants
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
|
Placebo (Sugar Pill)
n=6 Participants
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
|
|---|---|---|
|
Change in Waist Circumference
|
106.09 cm
Standard Deviation 8.8
|
108.37 cm
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: The number of participants for analysis (intent to treat) were those that completed the study.
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.
Outcome measures
| Measure |
Ramelteon
n=14 Participants
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
|
Placebo (Sugar Pill)
n=6 Participants
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
|
|---|---|---|
|
Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
|
2.4 HOMA score
Standard Deviation 1.51
|
2.36 HOMA score
Standard Deviation 1.73
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: The number of participants for analysis (intent to treat) were those that completed the study.
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.
Outcome measures
| Measure |
Ramelteon
n=14 Participants
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
|
Placebo (Sugar Pill)
n=6 Participants
A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
|
|---|---|---|
|
Change in Abdominal Fat (DEXA).
|
3934.86 g
Standard Deviation 1151.97
|
5120.92 g
Standard Deviation 1770.58
|
Adverse Events
Ramelteon
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David C. Henderson, M.D.
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place