Psychopharmacological Treatment of Emotional Distress

Psychological Distress Clinical Trial

Official title:

Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133114
• Other study ID #: STUDY-22-01296
• Status: Recruiting
• Phase: Phase 4
• Start date: May 2024
• Est. completion date: October 2026

Study information

• Verified date: March 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Igor Galynker, MD,PhD
• Phone: 212 420 4535
• Email: igor.galynker[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychological Distress
• Suicide

Intervention

Drug:
• Clonazepam
0.5 mg twice a day (1 mg a day)
• Olanzapine
2.5 mg once a day of Olanzapine
• Buprenorphine
2 mg once a day of Buprenorphine

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicide Crisis Syndrome-Checklist (SCS-C)	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.	up to 1 month follow up after discharge
Secondary	Suicide Crisis Inventory-Short Form (SCI-SF) for Severity	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.	up to 1 month follow up after discharge