Psychopharmacological Treatment of Emotional Distress

NCT06133114 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY-22-01296
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide Crisis Syndrome; Psychological Distress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Suicide Crisis Inventory-Short Form (SCI-SF) for Severity

  up to 1 month follow up after discharge

Study Arms (4)

S arm: Single drug clonazepam

EXPERIMENTAL

Single drug clonazepam: 1 mg a day (0.5 mg twice a day) with Treatment As Usual (TAU)

Drug: Clonazepam

D arm: Two-drug combination clonazepam/olanzapine

EXPERIMENTAL

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)

Drug: Clonazepam; Drug: Olanzapine

T arm: Three-drug combination clonazepam/olanzapine/buprenorphine

EXPERIMENTAL

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)

Drug: Clonazepam; Drug: Olanzapine; Drug: Buprenorphine

Control Group

NO INTERVENTION

Participants that will not receive an intervention.

Interventions

Clonazepam DRUG

0.5 mg twice a day (1 mg a day)

Also known as: TAU

D arm: Two-drug combination clonazepam/olanzapine; S arm: Single drug clonazepam; T arm: Three-drug combination clonazepam/olanzapine/buprenorphine

Olanzapine DRUG

2.5 mg once a day of Olanzapine

D arm: Two-drug combination clonazepam/olanzapine; T arm: Three-drug combination clonazepam/olanzapine/buprenorphine

Buprenorphine DRUG

2 mg once a day of Buprenorphine

T arm: Three-drug combination clonazepam/olanzapine/buprenorphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

Clonazepam; Olanzapine; Buprenorphine

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Igor Galynker, MD,PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Galynker, MD,PhD

CONTACT

212 420 4535; igor.galynker@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: March 13, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)