Psychopharmacological Treatment of Emotional Distress

ID#: NCT06133114

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 4

Recruitment Status: Recruiting

Start Date: February 01, 2024

End Date: October 01, 2026

Contact Information:
Igor Galynker, MD,PhD
212 420 4535
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.
Eligibility:

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.
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