NCT06133114

Psychopharmacological Treatment of Emotional Distress

Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Suicide Crisis Syndrome
• Psychological Distress

Interventions

Type	Name	Description
DRUG	Clonazepam	0.5 mg twice a day (1 mg a day)
DRUG	Olanzapine	2.5 mg once a day of Olanzapine
DRUG	Buprenorphine	2 mg once a day of Buprenorphine

Timeline

• Start date: 2024-03-13
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-11-15
• Last updated: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study