drugset / Trial / NCT06133114
Psychopharmacological Treatment of Emotional Distress
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-03-13
- Primary completion
- 2026-10
- Completion
- 2026-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 2 mg | — |
| Subject | Clonazepam | Small molecule | 0.5 mg | — |
| Subject | Olanzapine | Small molecule | 2.5 mg | — |
Indications
No indication recorded.