Psychopharmacological Treatment of Emotional Distress

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Martina Sobrero, MD
martina.sobrero@mssm.edu

More Details

Status
Recruiting
Sponsor
Icahn School of Medicine at Mount Sinai

Study Contact

Igor Galynker, MD,PhD
212 420 4535
igor.galynker@mountsinai.org