Trial Outcomes & Findings for Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder (NCT NCT02527564)
NCT ID: NCT02527564
Last Updated: 2022-10-06
Results Overview
Measured by self-report electronic sleep diary. Change is calculated as week 1 value minus week 0 value.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
baseline and week 1 of double-blind, placebo-controlled phase
Results posted on
2022-10-06
Participant Flow
61 participants consented, 48 participants were randomized to a study arm.
Participant milestones
| Measure |
Suvorexant (Double-blind)
Participants receive double-blind suvorexant for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights.
|
Placebo (Double-blind)
Participants receive double-blind placebo to match suvorexant for one week.
|
Suvorexant (Open-label)
Participants receive open-label suvorexant for 3 months, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the remainder of 3 months.
|
|---|---|---|---|
|
Double-blind Phase (1 Week)
STARTED
|
23
|
25
|
0
|
|
Double-blind Phase (1 Week)
Received Allocated Intervention
|
19
|
17
|
0
|
|
Double-blind Phase (1 Week)
COMPLETED
|
22
|
24
|
0
|
|
Double-blind Phase (1 Week)
NOT COMPLETED
|
1
|
1
|
0
|
|
Open-label Phase (3 Months)
STARTED
|
0
|
0
|
46
|
|
Open-label Phase (3 Months)
COMPLETED
|
0
|
0
|
26
|
|
Open-label Phase (3 Months)
NOT COMPLETED
|
0
|
0
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Suvorexant
n=19 Participants
Participants receive double-blind suvorexant for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights. Following the double-blind phase, participants receive open-label suvorexant for 3 months, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the remainder of 3 months.
|
Placebo
n=17 Participants
Participants receive double-blind placebo to match suvorexant for one week. Following the double-blind phase, participants receive open-label suvorexant for 3 months, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the remainder of 3 months.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.84 years
STANDARD_DEVIATION 14.792 • n=5 Participants
|
44.53 years
STANDARD_DEVIATION 14.841 • n=7 Participants
|
48.92 years
STANDARD_DEVIATION 15.197 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi/Other
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and week 1 of double-blind, placebo-controlled phasePopulation: Participants who received the allocated intervention and with data at all time points are included in the analysis. This outcome was assessed in the double-blind groups only.
Measured by self-report electronic sleep diary. Change is calculated as week 1 value minus week 0 value.
Outcome measures
| Measure |
Suvorexant (Double-blind)
n=14 Participants
Participants receive double-blind suvorexant for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights.
|
Placebo (Double-blind)
n=10 Participants
Participants receive double-blind placebo to match suvorexant for one week.
|
|---|---|---|
|
Change in Subjective Total Sleep Time - Acute
week 0
|
7.04 hours
Standard Deviation 1.16
|
7.03 hours
Standard Deviation 0.55
|
|
Change in Subjective Total Sleep Time - Acute
week 1
|
7.53 hours
Standard Deviation 1.43
|
7.20 hours
Standard Deviation 0.68
|
|
Change in Subjective Total Sleep Time - Acute
change at week 1
|
0.49 hours
Standard Deviation 1.03
|
0.17 hours
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: baseline and week 1 of double-blind, placebo-controlled phasePopulation: Participants who received the allocated intervention and with data at all time points are included in the analysis. This outcome was assessed in the double-blind groups only.
Measured by actigraphy. Change is calculated as week 1 value minus week 0 value.
Outcome measures
| Measure |
Suvorexant (Double-blind)
n=14 Participants
Participants receive double-blind suvorexant for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights.
|
Placebo (Double-blind)
n=10 Participants
Participants receive double-blind placebo to match suvorexant for one week.
|
|---|---|---|
|
Change in Objective Total Sleep Time - Acute
week 0
|
6.46 hours
Standard Deviation 2.06
|
9.50 hours
Standard Deviation 4.64
|
|
Change in Objective Total Sleep Time - Acute
week 1
|
7.20 hours
Standard Deviation 2.60
|
10.10 hours
Standard Deviation 4.10
|
|
Change in Objective Total Sleep Time - Acute
change at week 1
|
0.74 hours
Standard Deviation 1.17
|
0.61 hours
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: week 1 and month 3 of open treatment phasePopulation: Participants who received the allocated intervention and with data at all time points are included in the analysis. Month 3 data were collected using last observation carried forward method (LOCF). This outcome was assessed in the open-label group only.
Measured by self-report electronic sleep diary. Change is calculated as the month 3 value minus the week 1 value
Outcome measures
| Measure |
Suvorexant (Double-blind)
n=24 Participants
Participants receive double-blind suvorexant for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights.
|
Placebo (Double-blind)
Participants receive double-blind placebo to match suvorexant for one week.
|
|---|---|---|
|
Subjective Total Sleep Time - Subchronic
week 1
|
7.24 hours
Standard Deviation 1.32
|
—
|
|
Subjective Total Sleep Time - Subchronic
month 3
|
7.25 hours
Standard Deviation 1.56
|
—
|
|
Subjective Total Sleep Time - Subchronic
change at month 3
|
0.01 hours
Standard Deviation 1.29
|
—
|
SECONDARY outcome
Timeframe: week 1 and month 3 of open treatment phasePopulation: Participants who received the allocated intervention and with data at all time points are included in the analysis. Month 3 data were collected using last observation carried forward method (LOCF). This outcome was assessed in the open-label group only.
Measured by actigraphy. Change is measured as the month 3 value minus the week 1 value.
Outcome measures
| Measure |
Suvorexant (Double-blind)
n=24 Participants
Participants receive double-blind suvorexant for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights.
|
Placebo (Double-blind)
Participants receive double-blind placebo to match suvorexant for one week.
|
|---|---|---|
|
Change in Objective Total Sleep Time - Subchronic
week 1
|
8.69 hours
Standard Deviation 3.44
|
—
|
|
Change in Objective Total Sleep Time - Subchronic
month 3
|
9.58 hours
Standard Deviation 4.56
|
—
|
|
Change in Objective Total Sleep Time - Subchronic
change at month 3
|
0.88 hours
Standard Deviation 3.82
|
—
|
Adverse Events
Suvorexant (Double-blind)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (Double-blind)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Suvorexant (Open-label)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Suvorexant (Double-blind)
n=23 participants at risk
Participants receive double-blind suvorexant for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights.
|
Placebo (Double-blind)
n=25 participants at risk
Participants receive double-blind placebo to match suvorexant for one week.
|
Suvorexant (Open-label)
n=46 participants at risk
Participants receive open-label suvorexant for 3 months, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the remainder of 3 months.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Breast Drainage
|
0.00%
0/23 • 1 week in the double-blind phase, and 3 months in the open-label phase
|
4.0%
1/25 • 1 week in the double-blind phase, and 3 months in the open-label phase
|
0.00%
0/46 • 1 week in the double-blind phase, and 3 months in the open-label phase
|
Other adverse events
| Measure |
Suvorexant (Double-blind)
n=23 participants at risk
Participants receive double-blind suvorexant for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights.
|
Placebo (Double-blind)
n=25 participants at risk
Participants receive double-blind placebo to match suvorexant for one week.
|
Suvorexant (Open-label)
n=46 participants at risk
Participants receive open-label suvorexant for 3 months, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the remainder of 3 months.
|
|---|---|---|---|
|
Psychiatric disorders
Hypersomnolence
|
4.3%
1/23 • 1 week in the double-blind phase, and 3 months in the open-label phase
|
4.0%
1/25 • 1 week in the double-blind phase, and 3 months in the open-label phase
|
6.5%
3/46 • 1 week in the double-blind phase, and 3 months in the open-label phase
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER