Suvorexant (Belsomra) for the Treatment of Bipolar Depression With Insomnia

NCT ID: NCT03764683

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-26
• Study Completion Date: 2021-01-06

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 out if suvorexant (Belsomra) is safe to take without causing too many side effects in people with bipolar disorder.

Suvorexant (Belsomra) is approved by the U.S. Food and Drug Administration (FDA) to treat insomnia. It has not yet been studied in people with bipolar disorder who have problems sleeping.

This research study will compare suvorexant (Belsomra) to placebo. The placebo looks exactly like suvorexant (Belsomra), but contains no suvorexant (Belsomra). During this study participants may get a placebo instead of suvorexant (Belsomra). Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.

This study has two parts, each lasting 6 weeks. During each part, participants may receive either Belsomra or placebo. Some participants will receive suvorexant for both parts, some will receive placebo for both parts, and others will receive suvorexant during one part and placebo during the other part. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.

This study is open to people with bipolar disorder who have trouble sleeping. Bipolar disorder is a brain disorder associated with episodes of mood swings ranging from depressive lows to manic highs.

About 80 subjects will take part in this research study. All subjects will be enrolled at Massachusetts General Hospital (MGH).

Conditions

Bipolar Disorder; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug-Drug

This arm will receive the active drug in the first and second phase of the study.

Group Type: EXPERIMENTAL

Suvorexant (Belsomra)

Intervention Type: DRUG

Suvorexant (Belsomra) is approved by the U.S. Food and Drug Administration (FDA) to treat insomnia. It has not yet been studied in people with bipolar disorder who have problems sleeping.

Placebo-Drug

This arm will receive placebo in the first phase of the study and the active drug in the second phase.

Group Type: OTHER

Suvorexant (Belsomra)

Intervention Type: DRUG

Suvorexant (Belsomra) is approved by the U.S. Food and Drug Administration (FDA) to treat insomnia. It has not yet been studied in people with bipolar disorder who have problems sleeping.

Placebo

Intervention Type: DRUG

Subjects will take placebo capsules (containing no active substance) identical in appearance to those containing Suvorexant

Placebo-Placebo

This arm will receive placebo in the first phase and second phase of the study.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will take placebo capsules (containing no active substance) identical in appearance to those containing Suvorexant

Interventions

Suvorexant (Belsomra)

Suvorexant (Belsomra) is approved by the U.S. Food and Drug Administration (FDA) to treat insomnia. It has not yet been studied in people with bipolar disorder who have problems sleeping.

Intervention Type: DRUG

Placebo

Subjects will take placebo capsules (containing no active substance) identical in appearance to those containing Suvorexant

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men or women between the ages of 18 and 75.

2. DSM V diagnosis of Bipolar Disorder Type I and II.

3. Ability to sign the Informed Consent Form.

4. Not taking an antidepressant medication within the past 14 days.

5. Meets criteria for a current major depressive episode as defined and operationalized by the MINI.

6. 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.

7. Scores >15 on the QIDS-SR.

8. Does not meet criteria for current hypomanic or manic episode as defined and operationalized by the MINI 7.0.2.

9. Patients must be stable on their bipolar medications for at least 1 month (4 weeks) prior to screening.

Exclusion Criteria

1. Unable to sign the Informed Consent Form.

2. Declines to participate.

3. DSM-V diagnosis of Psychosis, Schizophrenia, Schizoaffective Bipolar type.

4. Meets criteria for current hypomanic or manic episode as defined and operationalized by the MINI.

5. 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).

1. 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

2. 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).

3. Any lifetime history of serious or recurrent suicidal behavior.

4. In the investigator's judgment further risk assessment or exclusion due to suicidality is required.

7. Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.

8. 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.

9. Patients meeting criteria for current bipolar mixed episode as defined and operationalized by the MINI.

10. Patients with mood congruent or mood incongruent psychotic features.

11. Clinical or laboratory evidence of hypothyroidism.

12. Patients previously treated with Suvorexant (Belsomra)

13. Patients who have taken an investigational psychotropic drug within the last 60 days.

14. 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.

15. Previous treatment with the following procedures: ECT, vagus nerve stimulation, or deep brain stimulation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrew A. Nierenberg, MD

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustavo Kinrys, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

2018P002157

Identifier Type: -

Identifier Source: org_study_id