Psychopharmacological Treatment of Emotional Distress

Mount Sinai Health System

Status and phase: Enrolling; Phase 4

Conditions: Suicide Crisis Syndrome; Psychological Distress

Treatments: Drug: Clonazepam; Drug: Olanzapine; Drug: Buprenorphine

Study type: Interventional

Funder types: Other

Identifiers

NCT06133114

STUDY-22-01296

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

S arm: Single drug clonazepam

Experimental group

Description:

Single drug clonazepam: 1 mg a day (0.5 mg twice a day) with Treatment As Usual (TAU)

Treatment:

Drug: Clonazepam

D arm: Two-drug combination clonazepam/olanzapine

Experimental group

Description:

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)

Treatment:

Drug: Olanzapine

Drug: Clonazepam

T arm: Three-drug combination clonazepam/olanzapine/buprenorphine

Experimental group

Description:

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)

Treatment:

Drug: Buprenorphine

Drug: Olanzapine

Drug: Clonazepam

Control Group

No Intervention group

Description:

Participants that will not receive an intervention.