drugset / Trial / NCT06133114

Psychopharmacological Treatment of Emotional Distress

NCT06133114

Phase 4 Recruiting 80 enrolled Icahn School of Medicine at Mount Sinai
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-03-13
Primary completion
2026-10
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 2 mg
Subject Clonazepam Small molecule 0.5 mg
Subject Olanzapine Small molecule 2.5 mg

Indications

No indication recorded.