Psychopharmacological Treatment of Emotional Distress
Withdrawn before enrolling · Phase 4
Conditions studied: Suicide Crisis Syndrome, Psychological Distress
In brief
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.
Key facts
- Study ID
- NCT06133114
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 0
- Starts
- 2024-03-13
- Expected to finish
- 2024-03-13
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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