Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial
Icahn School of Medicine at Mount Sinai
Summary
This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with treatment as usual (TAU arm) in the treatment of emotional distress, specifically the Suicide Crisis Syndrome (SCS). All participants in experimental arms receive 2-day pulse treatments targeting four out of five of the acute emotional distress symptoms. The primary outcome measure is SCS at discharge and one-month follow-up. The secondary outcome measures include questions about suicidal behaviors associated with emotional distress at a one-month follow-up.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient admitted to an inpatient unit and ruled in for SCS diagnosis using SCS-C * Willing to stay in the hospital voluntarily, if medically necessary, for at least 4 days after enrolling in the study. * Patient admitted to an inpatient unit as a result of a recent (i.e., past-month) suicide attempt, as defined by the C-SSRS (Columbia Suicide Rating Scale). * Admitted to an inpatient unit in the last 36 hrs. * Able to understand the nature and the substance of the consent form. * Currently domiciled. * Able and willing to provide verifiable contact information for follow…
Interventions
- DrugClonazepam
0.5 mg twice a day (1 mg a day)
- DrugOlanzapine
2.5 mg once a day of Olanzapine
- DrugBuprenorphine
2 mg once a day of Buprenorphine
Location
- Icahn School of Medicine at Mount SinaiNew York, New York