Psychopharmacological Treatment of Emotional Distress

• Status: Recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Buprenorphine; Clonazepam; Olanzapine

Criteria

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-up.

Exclusion Criteria:

• Intellectual disability, cognitive impairment, or linguistic limitation precluding understanding of the consent or research questions.

• Past adverse reactions to clonazepam, olanzapine, or buprenorphine

• Past history of opiate or benzodiazepine use d/o in the last 2 years

• On agonist therapy for opiate addiction

• Ongoing treatment with clonazepam or olanzapine.

• Significant medical or neurological disease or possible delirium that might interfere with study participation or capacity to provide informed consent.

• Receiving involuntary treatment in psychiatric unit

• Clinical suspicion of malingering by a CP.

• Undomiciled.