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Search / Trial NCT06133114

Psychopharmacological Treatment of Emotional Distress

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Nov 10, 2023

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying different medication treatments for people experiencing severe emotional distress, specifically those diagnosed with Suicide Crisis Syndrome (SCS). Researchers want to find out how effective a single medication called clonazepam, a combination of clonazepam and olanzapine, and a three-drug combination including buprenorphine are, compared to the usual treatment. All participants will receive a special treatment over two days that aims to reduce their distressing symptoms. The main goal is to see how well these treatments work when participants are discharged from the hospital and one month later.

To participate in this trial, individuals must be admitted to the hospital due to a recent suicide attempt and be willing to stay for at least four days after joining the study. They should also be able to understand the consent form and provide contact information for follow-up. Participants can expect to receive close monitoring and support during their stay, as well as potential access to innovative treatment options. It's important to note that individuals with certain medical conditions, past negative reactions to the study medications, or who are currently receiving involuntary treatment may not be eligible to participate.

Gender

ALL

Eligibility criteria

  • 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.

About Icahn School Of Medicine At Mount Sinai

The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Igor Galynker, MD,PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported