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Recruiting Phase 4 NCT06133114

Psychopharmacological Treatment of Emotional Distress

Trial Parameters

Condition Suicide Crisis Syndrome
Sponsor Icahn School of Medicine at Mount Sinai
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-03-13
Completion 2026-10
Interventions
ClonazepamOlanzapineBuprenorphine

Brief 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 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. * Sign

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