Psychopharmacological Treatment of Emotional Distress

Phase 4

Recruiting

• Conditions: Psychological Distress; Suicide Crisis Syndrome
• Interventions: Drug: Clonazepam; Drug: Olanzapine; Drug: Buprenorphine

• Registration Number: NCT06133114
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-15
• Study Start: 2024-03-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T arm: Three-drug combination clonazepam/olanzapine/buprenorphine	Buprenorphine	Three-drug combination clonazepam/olanzapine/buprenorphine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine plus 2mg a day of Buprenorphine with Treatment As Usual (TAU)
T arm: Three-drug combination clonazepam/olanzapine/buprenorphine	Clonazepam	Three-drug combination clonazepam/olanzapine/buprenorphine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine plus 2mg a day of Buprenorphine with Treatment As Usual (TAU)
S arm: Single drug clonazepam	Clonazepam	Single drug clonazepam: 1 mg a day (0.5 mg twice a day) with Treatment As Usual (TAU)
D arm: Two-drug combination clonazepam/olanzapine	Clonazepam	Two-drug combination clonazepam/olanzapine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine with Treatment As Usual (TAU)
D arm: Two-drug combination clonazepam/olanzapine	Olanzapine	Two-drug combination clonazepam/olanzapine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine with Treatment As Usual (TAU)
T arm: Three-drug combination clonazepam/olanzapine/buprenorphine	Olanzapine	Three-drug combination clonazepam/olanzapine/buprenorphine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine plus 2mg a day of Buprenorphine with Treatment As Usual (TAU)

Primary Outcome Measures

Name	Time	Method
Suicide Crisis Syndrome-Checklist (SCS-C)	up to 1 month follow up after discharge	The SCS-C is a clinician rated measure assessing clinicians' assessment of the presence and intensity of the Suicide Crisis Syndrome among their patients. The SCS-C includes 13 dichotomous items reflecting the presence or absence of the SCS symptoms. The SCS-C also assesses the presence of the five SCS criteria (entrapment, affective disturbances, loss of cognitive control, hyperarousal and social withdrawal). The first item is a clinician rating of entrapment (SCS criterion A), rated as yes or no. The second item assesses the 4 domains of SCS criterion B: affective disturbance, loss of cognitive control, hyperarousal, and social withdrawal.; This item is rated yes if the patient exhibits 1 of the domains. A final rating is recorded as positive if both criteria A and B are rated as yes. A positive rating in the final rating reflects a positive SCS diagnosis.

Secondary Outcome Measures

Name	Time	Method
Suicide Crisis Inventory-Short Form (SCI-SF) for Severity	up to 1 month follow up after discharge	The SCI-SF is an 8-item version of the original 49-item Suicide Crisis Inventory that assesses the severity of different cognitive and affective states theorized in the SCS. Patients rate how they feel on a 5-point scale ranging from 0 (not at all) to 4 (extremely), with higher scores indicating more severe symptoms.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States