Actively Recruiting
Psychopharmacological Treatment of Emotional Distress
Led by Icahn School of Medicine at Mount Sinai · Updated on 2024-06-07
80
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Psychopharmacological Treatment of Emotional Distress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient admitted to an inpatient unit and diagnosed with Suicide Crisis Syndrome using the SCS-C
- Willing to remain voluntarily in the hospital for at least 4 days after enrolling
- Admitted to an inpatient unit due to a suicide attempt within the past month, as defined by the Columbia Suicide Severity Rating Scale
- Admitted to an inpatient unit within the last 36 hours
- Able to understand and consent to the study
- Currently living in a stable residence
- Able and willing to provide contact information for follow-up
You will not qualify if you...
- Intellectual disability, cognitive impairment, or language barriers preventing understanding of consent or research questions
- Past adverse reactions to clonazepam, olanzapine, or buprenorphine
- History of opiate or benzodiazepine use disorder within the last 2 years
- Currently receiving agonist therapy for opiate addiction
- Ongoing treatment with clonazepam or olanzapine
- Significant medical or neurological illness or possible delirium interfering with participation or consent
- Receiving involuntary psychiatric treatment
- Suspicion of malingering by a clinical psychiatrist
- Not currently living in a stable residence
AI-Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
I
Igor Galynker, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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