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NCT06133114 · ClinicalTrials.gov registry record · Phase 4
Psychopharmacological Treatment of Emotional Distress
A Phase 4 study of Psychological Distress and Suicide Crisis Syndrome, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06133114 is a Phase 4 study of Psychological Distress and Suicide Crisis Syndrome that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 80 participants, below the 470-participant average among 28 other Psychological Distress trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06133114, a Phase 4 study of Psychological Distress and Suicide Crisis Syndrome, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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/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 Studied
Interventions
- DRUG Olanzapine
- DRUG Buprenorphine
- DRUG Clonazepam
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-03-13 |
| Est. Completion | 2026-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06133114
The ClinicalTrials.gov registry entry for NCT06133114 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 470-participant average among 28 other Psychological Distress trials with a reported enrollment target (83% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Psychological Distress appearing as the primary indexed condition, and to 3 interventions - of which Olanzapine is the first listed.
NCT06133114 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06133114 about?
NCT06133114 is a clinical study titled "Psychopharmacological Treatment of Emotional Distress". 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, sp...
What is the current status of trial NCT06133114?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2024-03-13. Estimated completion is 2026-10.
What conditions does trial NCT06133114 study?
This clinical trial studies the following conditions: Psychological Distress, Suicide Crisis Syndrome.
What interventions are being tested in trial NCT06133114?
The interventions under investigation include: Olanzapine (DRUG), Buprenorphine (DRUG), Clonazepam (DRUG).
Who is sponsoring clinical trial NCT06133114?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06133114 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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