Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/6/2017 |
| Start Date: | September 2015 |
| End Date: | August 2018 |
| Contact: | Lauren Chang, B.S. |
| Email: | laurensc@stanford.edu |
| Phone: | 650-498-8459 |
A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder
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 duration compared to participants receiving
placebo.
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 duration compared to participants receiving
placebo.
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.
after which all participants will receive open treatment with suvorexant for three months.
Inclusion Criteria:
1. 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).
2. Currently taking ≥ 1 prescription psychotropic medication (hypnotic agents,
anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for
management of bipolar disorder.
3. Subjective total sleep time (sTST) < 6 hours on ≥ 1 night during the prior week.
Exclusion Criteria:
1. Current hypo/manic symptoms, as evidenced by YMRS total score ≥ 12.
2. Current (past 6 months) alcohol or substance use disorder.
3. Current psychosis.
4. Patients who are actively suicidal or evaluated as being a high suicide risk.
5. Women who are currently pregnant or breastfeeding.
6. Clinically significant abnormalities on baseline laboratory tests (comprehensive
metabolic panel, fasting lipid panel, CBC with differential, thyroid stimulating
hormone).
7. Presence of any unstable and/or potentially confounding neurological and/or medical
disorder.
We found this trial at
1
site
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
Click here to add this to my saved trials
