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Psychopharmacological Treatment of Emotional Distress
Sponsor: 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.
Official title: Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-03-13
Completion Date
2026-10
Last Updated
2024-06-07
Healthy Volunteers
No
Interventions
Clonazepam
0.5 mg twice a day (1 mg a day)
Olanzapine
2.5 mg once a day of Olanzapine
Buprenorphine
2 mg once a day of Buprenorphine
Locations (1)
Icahn School of Medicine at Mount Sinai
New York, New York, United States