Treatment for emotional distress related to suicide crisis

Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial

This study is testing different combinations of medications to see if they can help people in emotional distress from a suicide crisis feel better compared to standard treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06133114 on ClinicalTrials.gov

What this trial studies

This clinical trial is an inpatient randomized control trial that compares the effectiveness of three different drug combinations—single drug clonazepam, a two-drug combination of clonazepam and olanzapine, and a three-drug combination of clonazepam, olanzapine, and buprenorphine—against standard treatment for patients experiencing emotional distress due to Suicide Crisis Syndrome. Participants will receive a 2-day pulse treatment targeting acute emotional distress symptoms, with outcomes measured at discharge and one month later. The primary focus is on reducing symptoms of the Suicide Crisis Syndrome and assessing suicidal behaviors.

Who should consider this trial

Good fit: Ideal candidates are patients admitted to an inpatient unit with a recent suicide attempt and diagnosed with Suicide Crisis Syndrome.

Not a fit: Patients with cognitive impairments or those who have had adverse reactions to the study medications may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce emotional distress and suicidal behaviors in patients experiencing a crisis.

How similar studies have performed: While this approach is novel in its specific combination of medications, similar studies have shown promise in treating emotional distress and suicidal behaviors.

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.

Where this trial is running

New York, New York

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Igor Galynker, MD,PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Igor Galynker, MD,PhD

Conditions Suicide Crisis Syndrome; Psychological Distress