Psychopharmacological Treatment of Emotional Distress

Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Psychological Distress; Suicide Crisis Syndrome
• Intervention / Treatment: Drug: Clonazepam; Drug: Olanzapine; Drug: Buprenorphine

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Igor Galynker, MD,PhD; Phone Number: 212 420 4535; Email: igor.galynker@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Martina Sobrero, MD; Email: martina.sobrero@mssm.edu
      • Contact: Rawad El Hayek, MD; Email: rawad.elhayek@mssm.edu
      • Principal Investigator: Igor Galynker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S arm: Single drug clonazepam; Single drug clonazepam: 1 mg a day (0.5 mg twice a day) with Treatment As Usual (TAU)	Drug: Clonazepam; 0.5 mg twice a day (1 mg a day); Other Names: TAU
Experimental: D arm: Two-drug combination clonazepam/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)	Drug: Clonazepam; 0.5 mg twice a day (1 mg a day); Other Names: TAU; Drug: Olanzapine; 2.5 mg once a day of Olanzapine
Experimental: T arm: Three-drug combination clonazepam/olanzapine/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)	Drug: Clonazepam; 0.5 mg twice a day (1 mg a day); Other Names: TAU; Drug: Olanzapine; 2.5 mg once a day of Olanzapine; Drug: Buprenorphine; 2 mg once a day of Buprenorphine
No Intervention: Control Group; Participants that will not receive an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Igor Galynker, MD,PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; GABA Modulators; GABA Agents; Narcotic Antagonists; Anticonvulsants; Selective Serotonin Reuptake Inhibitors; Olanzapine; Buprenorphine; Clonazepam
• Other Study ID Numbers: STUDY-22-01296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared. Results will be published by the investigator in individual journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No