Psychopharmacological Treatment of Emotional Distress

Description

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

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Study Overview

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Study Details

Study 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.

Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial

Psychopharmacological Treatment of Emotional Distress

Condition
Suicide Crisis Syndrome
Intervention / Treatment

-

Contacts and Locations

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Igor Galynker, MD,PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2026-10