Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stanford University
With
Merck Sharp & Dohme LLC
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
1. Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (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.
