Psychopharmacological Treatment of Emotional Distress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2026-10-31

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.

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Detailed Description

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Conditions

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Suicide Crisis Syndrome Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S arm: Single drug clonazepam

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

Group Type EXPERIMENTAL

Clonazepam

Intervention Type DRUG

0.5 mg twice a day (1 mg a day)

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)

Group Type EXPERIMENTAL

Clonazepam

Intervention Type DRUG

0.5 mg twice a day (1 mg a day)

Olanzapine

Intervention Type DRUG

2.5 mg once a day of Olanzapine

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)

Group Type EXPERIMENTAL

Clonazepam

Intervention Type DRUG

0.5 mg twice a day (1 mg a day)

Olanzapine

Intervention Type DRUG

2.5 mg once a day of Olanzapine

Buprenorphine

Intervention Type DRUG

2 mg once a day of Buprenorphine

Control Group

Participants that will not receive an intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clonazepam

0.5 mg twice a day (1 mg a day)

Intervention Type DRUG

Olanzapine

2.5 mg once a day of Olanzapine

Intervention Type DRUG

Buprenorphine

2 mg once a day of Buprenorphine

Intervention Type DRUG

Other Intervention Names

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TAU

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No