Psychopharmacological Treatment of Emotional Distress

Study Overview
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Brief Summary
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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.

Official Title
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Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial

Conditions
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Suicide Crisis Syndrome, Psychological Distress

Intervention / Treatment
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* Drug: Clonazepam
* Drug: Olanzapine
* Drug: Buprenorphine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S arm: Single drug clonazepam<br>Single drug clonazepam: 1 mg a day (0.5 mg twice a day) with Treatment As Usual (TAU) | Drug: Clonazepam<br>* 0.5 mg twice a day (1 mg a day)<br>* Other names: TAU;|
| Experimental: D arm: Two-drug combination clonazepam/olanzapine<br>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<br>* 0.5 mg twice a day (1 mg a day)<br>* Other names: TAU;Drug: Olanzapine<br>* 2.5 mg once a day of Olanzapine<br>|
| Experimental: T arm: Three-drug combination clonazepam/olanzapine/buprenorphine<br>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<br>* 0.5 mg twice a day (1 mg a day)<br>* Other names: TAU;Drug: Olanzapine<br>* 2.5 mg once a day of Olanzapine<br>Drug: Buprenorphine<br>* 2 mg once a day of Buprenorphine<br>|
| No Intervention: Control Group<br>Participants that will not receive an intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide Crisis Syndrome-Checklist (SCS-C) | 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. | up to 1 month follow up after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide Crisis Inventory-Short Form (SCI-SF) for Severity | 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. | up to 1 month follow up after discharge |