NCT03764683

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

Withdrawn Phase 4 Last updated 21 February 2021

What this trial tests

Phase 4 trial testing Suvorexant (Belsomra) in Bipolar Disorder. Withdrawn.

Timeline

26 February 2019

Primary endpoint
6 January 2021

6 January 2021

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Start date	26 February 2019
Primary completion	6 January 2021
Estimated completion	6 January 2021

Drugs / interventions tested

• Suvorexant (Belsomra) — full drug profile →
• Placebo

Conditions studied

• Bipolar Disorder — all drugs for Bipolar Disorder →
• Insomnia — all drugs for Insomnia →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 75, any sex, with Bipolar Disorder or Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Orexin receptor antagonists in the treatment of insomnia associated with psychiatric disorders: a systematic review.
   Kishi T, Koebis M, Sugawara M, Kawatsu Y, et al · · 2024 · cited 12× · PMID 39277609 · DOI 10.1038/s41398-024-03087-4
2. A new direction for adjunctive therapy of difficult-to-treat depression: examining the role of orexin receptor antagonists.
   Thase ME. · · 2025 · PMID 40434499 · DOI 10.1007/s00406-025-01999-w