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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of suvorexant, added to existing medications, for treatment-resistant insomnia in individuals with bipolar disorder. The investigators hypothesize that participants receiving suvorexant for one week will experience significantly greater improvement in sleep duration compared to participants receiving placebo.
Participants will be randomized to receive double-blind suvorexant or placebo for one week, after which all participants will receive open treatment with suvorexant for three months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suvorexant | Experimental | 50% of enrolled participants will be randomly assigned to 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 one-week double-blind, placebo-controlled phase, 100% of participants will 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 | Placebo Comparator | 50% of enrolled participants will be randomly assigned to receive double-blind placebo pill for one week, dosed at 10mg every bedtime for the first 3 nights, then increased to 20mg every bedtime for the last 4 nights. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subjective Total Sleep Time - Acute | Measured by self-report electronic sleep diary. Change is calculated as week 1 value minus week 0 value. | baseline and week 1 of double-blind, placebo-controlled phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Objective Total Sleep Time - Acute | Measured by actigraphy. Change is calculated as week 1 value minus week 0 value. | baseline and week 1 of double-blind, placebo-controlled phase |
| Subjective Total Sleep Time - Subchronic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Po Wang, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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61 participants consented, 48 participants were randomized to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo (Double-blind) | Participants receive double-blind placebo to match suvorexant for one week. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Phase (1 Week) |
| ||||||||||||||||
| Open-label Phase (3 Months) |
|
Participants who received the allocated intervention are included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Suvorexant | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Subjective Total Sleep Time - Acute | Measured by self-report electronic sleep diary. Change is calculated as week 1 value minus week 0 value. | 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. | Posted | Mean | Standard Deviation | hours | baseline and week 1 of double-blind, placebo-controlled phase |
|
1 week in the double-blind phase, and 3 months in the open-label phase
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Drainage | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersomnolence | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Po W. Wang | Stanford University | 650-723-2483 | wangp0@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2020 | Jul 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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| Drug |
|
Measured by self-report electronic sleep diary. Change is calculated as the month 3 value minus the week 1 value
| week 1 and month 3 of open treatment phase |
| Change in Objective Total Sleep Time - Subchronic | Measured by actigraphy. Change is measured as the month 3 value minus the week 1 value. | week 1 and month 3 of open treatment phase |
| NOT COMPLETED |
|
| BG001 | Placebo | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participants receive double-blind placebo to match suvorexant for one week.
|
|
|
| Secondary | Change in Objective Total Sleep Time - Acute | Measured by actigraphy. Change is calculated as week 1 value minus week 0 value. | 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. | Posted | Mean | Standard Deviation | hours | baseline and week 1 of double-blind, placebo-controlled phase |
|
|
|
|
| Secondary | Subjective Total Sleep Time - Subchronic | Measured by self-report electronic sleep diary. Change is calculated as the month 3 value minus the week 1 value | 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. | Posted | Mean | Standard Deviation | hours | week 1 and month 3 of open treatment phase |
|
|
|
|
| Secondary | Change in Objective Total Sleep Time - Subchronic | Measured by actigraphy. Change is measured as the month 3 value minus the week 1 value. | 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. | Posted | Mean | Standard Deviation | hours | week 1 and month 3 of open treatment phase |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | Placebo (Double-blind) | Participants receive double-blind placebo to match suvorexant for one week. | 0 | 25 | 1 | 25 | 1 | 25 |
| EG002 | 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. | 0 | 46 | 0 | 46 | 3 | 46 |
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| D001523 |
| Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| change at week 1 |
|
| Paired 2-sided t-test |
A p-value of <0.05 would be considered statistically significant. |
| 0.55 |
| Other |
| Between group change at week 1 | Paired 2-sided t-test | 0.89 | A p-value of <0.05 would be considered statistically significant. | Other |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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