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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.