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Psychopharmacological Treatment of Emotional Distress

Psychopharmacological Treatment of Emotional Distress

Recruiting
18 years and older
All
Phase 4

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Overview

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.

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.

Study details
    Suicide Crisis Syndrome
    Psychological Distress

NCT06133114

Icahn School of Medicine at Mount Sinai

17 June 2024

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