InsomniaPhase 4NCT02527564

Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

A Phase 4 study testing Suvorexant in people with Insomnia and Bipolar Disorder, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Insomnia, Bipolar Disorder
What is being tested?: Suvorexant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 1 siteUnited States
Study dates: Sep 2015to 1 Mar 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult outpatients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder (296.70), bipolar II disorder (296.89), or bipolar disorder not otherwise specified (296.80), with concurrent insomnia related to bipolar disorder (307.42).
Currently taking ≥ 1 prescription psychotropic medication (hypnotic agents, anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for management of bipolar disorder.
Subjective total sleep time (sTST) < 6 hours on ≥ 1 night during the prior week.

Who cannot join

Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (YMRS) total score ≥ 12.
Current (past 6 months) alcohol or substance use disorder.
Current psychosis.
Patients who are actively suicidal or evaluated as being a high suicide risk.
Women who are currently pregnant or breastfeeding.
Clinically significant abnormalities on baseline laboratory tests (comprehensive metabolic panel, fasting lipid panel, Complete Blood Count (CBC) with differential, thyroid stimulating hormone).
Presence of any unstable and/or potentially confounding neurological and/or medical disorder.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder

Read the detailed description

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.

Conditions: Insomnia, Bipolar Disorder
Being tested: Suvorexant, Placebo
Medical subject headings: Sleep Initiation and Maintenance Disorders, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SuvorexantDrug
Also called Belsomra
PlaceboDrug

Study groups in NCT02527564
Study group	Role	What they receive
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. Receives: Drug: Suvorexant
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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline and week 1 of double-blind, placebo-controlled phase

Secondary outcomes (3)

Change in Objective Total Sleep Time - Acute
Measured by actigraphy. Change is calculated as week 1 value minus week 0 value.
Measured: baseline and week 1 of double-blind, placebo-controlled phase
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
Measured: 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.
Measured: week 1 and month 3 of open treatment phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 20151 Mar 2021

First posted19 Aug 2015 (estimated)
Study startSep 2015
Primary completion1 Mar 2021
Study completion1 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02527564
Sponsor's protocol ID: 53208
Status last verified: Oct 2022
First submitted: 17 Aug 2015
Last updated: 6 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder
ClinicalTrials.gov ID: NCT02527564
Acronym / sponsor ID: 53208
Conditions: Insomnia, Bipolar Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Sep 2015
Primary completion: 1 Mar 2021 (actual)
Study completion: 1 Mar 2021 (actual)
First posted: 19 Aug 2015 (estimated)
Results: Posted 6 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Suvorexant	Experimental	Drug: Suvorexant50% 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	Drug: Placebo50% 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult outpatients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder (296.70), bipolar II disorder (296.89), or bipolar disorder not otherwise specified (296.80), with concurrent insomnia related to bipolar disorder (307.42).
Currently taking ≥ 1 prescription psychotropic medication (hypnotic agents, anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for management of bipolar disorder.
Subjective total sleep time (sTST) < 6 hours on ≥ 1 night during the prior week.

Key exclusion criteria (7 listed)

Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (YMRS) total score ≥ 12.
Current (past 6 months) alcohol or substance use disorder.
Current psychosis.
Patients who are actively suicidal or evaluated as being a high suicide risk.
Women who are currently pregnant or breastfeeding.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SuvorexantAlso: Belsomra	Drug	Suvorexant
Placebo	Drug	Placebo

Primary outcome

Change in Subjective Total Sleep Time - Acute
Time frame: baseline and week 1 of double-blind, placebo-controlled phase
Measured by self-report electronic sleep diary. Change is calculated as week 1 value minus week 0 value.

3 secondary outcomes

Change in Objective Total Sleep Time - Acute
Time frame: baseline and week 1 of double-blind, placebo-controlled phase
Subjective Total Sleep Time - Subchronic
Time frame: week 1 and month 3 of open treatment phase
Change in Objective Total Sleep Time - Subchronic
Time frame: week 1 and month 3 of open treatment phase

Results and safety

Results posted to the registry on 6 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Suvorexant (Double-blind)	23	22
Placebo (Double-blind)	25	24
Suvorexant (Open-label)	0	0

Primary outcome: Change in Subjective Total Sleep Time - Acute

Time frame: baseline and week 1 of double-blind, placebo-controlled phase. Mean (Standard Deviation). Unit: hours

Measure	Suvorexant (Double-blind) n = 14	Placebo (Double-blind) n = 10
week 0	7.04 (1.16)	7.03 (0.55)
week 1	7.53 (1.43)	7.20 (0.68)
change at week 1	0.49 (1.03)	0.17 (0.90)

Suvorexant (Double-blind): p = 0.10, Paired 2-sided t-test
Placebo (Double-blind): p = 0.57, Paired 2-sided t-test
Suvorexant (Double-blind) vs Placebo (Double-blind): p = 0.44, Unpaired 2-sided t-test

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 week in the double-blind phase, and 3 months in the open-label phase. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Suvorexant (Double-blind)	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23
Placebo (Double-blind)	1 of 25 (4%)	1 of 25 (4%)	0 of 25
Suvorexant (Open-label)	0 of 46 (0%)	3 of 46 (6.5%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Po Wang, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Suvorexant in people with Insomnia and Bipolar Disorder, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Subjective Total Sleep Time - Acute (time frame: baseline and week 1 of double-blind, placebo-controlled phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02527564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.