Psychopharmacological Treatment of Emotional Distress (NCT06133114) | Clinical Trial Compass
WithdrawnPhase 4
Psychopharmacological Treatment of Emotional Distress
Stopped: Enrollment was discontinued after limited accrual prevented feasible completion of the trial.
United States0Started 2024-03-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Suicide Crisis Syndrome-Checklist (SCS-C)
Timeframe: up to 1 month follow up after discharge