Status:
WITHDRAWN
Suvorexant (Belsomra) for the Treatment of Bipolar Depression With Insomnia
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Bipolar Disorder
Insomnia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The investigators are doing this research study to find out if suvorexant (Belsomra) can help people with bipolar depression when added to their usual treatment. The investigators also want to find ou...
Eligibility Criteria
Inclusion
- Men or women between the ages of 18 and 75.
- DSM V diagnosis of Bipolar Disorder Type I and II.
- Ability to sign the Informed Consent Form.
- Not taking an antidepressant medication within the past 14 days.
- Meets criteria for a current major depressive episode as defined and operationalized by the MINI.
- Patients must have a 10-item MADRS Rating Scale for Depression score ≥ 16 and item 4 (Reduced sleep) score ≥ 4 during the screening phase and at baseline to qualify for inclusion.
- Scores \>15 on the QIDS-SR.
- Does not meet criteria for current hypomanic or manic episode as defined and operationalized by the MINI 7.0.2.
- Patients must be stable on their bipolar medications for at least 1 month (4 weeks) prior to screening.
Exclusion
- Unable to sign the Informed Consent Form.
- Declines to participate.
- DSM-V diagnosis of Psychosis, Schizophrenia, Schizoaffective Bipolar type.
- Meets criteria for current hypomanic or manic episode as defined and operationalized by the MINI.
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence from intercourse; Depo Provera is acceptable if it is started 3 months prior to enrollment).
- Patients who are a serious suicide or homicide risk, suicidal exclusion criteria as follows:
- Suicidal ideation associated with actual intent and a method or plan in the past year: "Yes" answers on items 4 or 5 of the C-SSRS
- Previous history of suicidal behaviors in the past one year: "Yes" answer (for events that occurred in the past year) to any of the suicidal behavior items of the C-SSRS. (Non-suicidal self-injurious behavior is not included unless in the investigator's judgment it is indicated).
- Any lifetime history of serious or recurrent suicidal behavior.
- In the investigator's judgment further risk assessment or exclusion due to suicidality is required.
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
- The following DSM-V diagnoses: 1) organic mental disorders; 2) substance use disorders, including alcohol but excluding tobacco, active within the 3 months; 3) schizophrenia; 4) delusional disorder; 5) psychotic disorders not elsewhere classified; 6) schizoaffective disorder; 7) acute bereavement; 9) severe borderline or antisocial personality disorder.
- a. Subjects who have a positive urine drug screen which cannot be explained by prescribed medications, or for which patients do not have a valid prescription for a valid medical reason.
- Patients meeting criteria for current bipolar mixed episode as defined and operationalized by the MINI.
- Patients with mood congruent or mood incongruent psychotic features.
- Clinical or laboratory evidence of hypothyroidism.
- Patients previously treated with Suvorexant (Belsomra)
- Patients who have taken an investigational psychotropic drug within the last 60 days.
- Standard multivitamins with or without minerals will be allowed (with no more than 400 mcg folate) if initiated at least 12 weeks prior to Baseline. Dietary supplements with putative CNS activity will be excluded including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba.
- Previous treatment with the following procedures: ECT, vagus nerve stimulation, or deep brain stimulation.
Key Trial Info
Start Date :
February 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03764683
Start Date
February 26 2019
End Date
January 6 2021
Last Update
February 21 2021
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