Psychopharmacological Treatment of Emotional Distress
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: S arm: Single drug clonazepam Single drug clonazepam: 1 mg a day (0.5 mg twice a day) with Treatment As Usual (TAU) |
Drug: Clonazepam
0.5 mg twice a day (1 mg a day)
Other Names:
Drug: Treatment As Usual
The treatment the participant is already receiving by the medical team (pharmacological and therapy treatment). It does not involve any intervention from the research team.
Other Names:
|
| Experimental: D arm: Two-drug combination clonazepam/olanzapine Two-drug combination clonazepam/olanzapine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine with Treatment As Usual (TAU) |
Drug: Clonazepam
0.5 mg twice a day (1 mg a day)
Other Names:
Drug: Olanzapine
2.5 mg once a day of Olanzapine
Drug: Treatment As Usual
The treatment the participant is already receiving by the medical team (pharmacological and therapy treatment). It does not involve any intervention from the research team.
Other Names:
|
| Experimental: T arm: Three-drug combination clonazepam/olanzapine/buprenorphine Three-drug combination clonazepam/olanzapine/buprenorphine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine plus 2mg a day of Buprenorphine with Treatment As Usual (TAU) |
Drug: Clonazepam
0.5 mg twice a day (1 mg a day)
Other Names:
Drug: Olanzapine
2.5 mg once a day of Olanzapine
Drug: Buprenorphine
2 mg once a day of Buprenorphine
Drug: Treatment As Usual
The treatment the participant is already receiving by the medical team (pharmacological and therapy treatment). It does not involve any intervention from the research team.
Other Names:
|
| Other: Treatment As Usual (TAU) Treatment As Usual (TAU) |
Drug: Treatment As Usual
The treatment the participant is already receiving by the medical team (pharmacological and therapy treatment). It does not involve any intervention from the research team.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 scale 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 score in the final rating reflects a positive SCS diagnosis.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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).
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Admitted to an inpatient unit in the last 36 hrs.
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Able to understand the nature and the substance of the consent form.
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Currently domiciled.
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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
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Past history of opiate or benzodiazepine use d/o in the last 2 years
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On agonist therapy for opiate addiction
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Ongoing treatment with clonazepam or olanzapine.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
Investigators
- Principal Investigator: Igor Galynker, MD,PhD, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY-22-01296