Status:
RECRUITING
Psychopharmacological Treatment of Emotional Distress
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Suicide Crisis Syndrome
Psychological Distress
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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/olanzapin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06133114
Start Date
March 13 2024
End Date
October 1 2026
Last Update
June 7 2024
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029