Suvorexant (Belsomra) for the Treatment of Bipolar Depression With Insomnia
Status:
Withdrawn
Trial end date:
2021-01-06
Target enrollment:
Participant gender:
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).