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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: Recruiting Phase 4 study of Psychological Distress and Suicide Crisis Syndrome, sponsored by Icahn School of Medicine at Mount Sinai.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT06133114 shows while recruiting
NCT06133114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 470-participant average among 28 other Psychological Distress trials with a reported enrollment target (83% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Psychological Distress
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06133114's enrollment target sits among peer trials
80 13th of 28 higher than 15 of 28 other Psychological Distress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psychological Distress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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