Psychological Distress, Suicide Crisis Syndrome
Conditions
Brief 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.
Interventions
DRUGClonazepam
0.5 mg twice a day (1 mg a day)
DRUGOlanzapine
2.5 mg once a day of Olanzapine
DRUGBuprenorphine
2 mg once a day of Buprenorphine
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suicide Crisis Syndrome-Checklist (SCS-C) | up to 1 month follow up after discharge | The SCS-C is a clinician rated measure assessing clinicians' assessment of the presence and intensity of the Suicide Crisis Syndrome among their patients. The SCS-C includes 13 dichotomous items reflecting the presence or absence of the SCS symptoms. The SCS-C also assesses the presence of the five SCS criteria (entrapment, affective disturbances, loss of cognitive control, hyperarousal and social withdrawal). The first item is a clinician rating of entrapment (SCS criterion A), rated as yes or no. The second item assesses the 4 domains of SCS criterion B: affective disturbance, loss of cognitive control, hyperarousal, and social withdrawal. This item is rated yes if the patient exhibits 1 of the domains. A final rating is recorded as positive if both criteria A and B are rated as yes. A positive rating in the final rating reflects a positive SCS diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suicide Crisis Inventory-Short Form (SCI-SF) for Severity | up to 1 month follow up after discharge | The SCI-SF is an 8-item version of the original 49-item Suicide Crisis Inventory that assesses the severity of different cognitive and affective states theorized in the SCS. Patients rate how they feel on a 5-point scale ranging from 0 (not at all) to 4 (extremely), with higher scores indicating more severe symptoms. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORIgor Galynker, MD,PhD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed