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Opioid

Psychopharmacological Treatment for Psychological Distress

Phase 4

Recruiting

Led By Igor Galynker, MD,PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted to an inpatient unit in the last 36 hrs

Willing to stay in the hospital voluntarily, if medically necessary, for at least 4 days after enrolling in the study

Must not have

Ongoing treatment with clonazepam or olanzapine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month follow up after discharge

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests different treatments for emotional distress and suicidal behaviors in hospitalized patients.

Who is the study for?

This trial is for individuals recently hospitalized due to emotional distress or a suicide attempt, who can understand the study and agree to stay in the hospital for at least 4 days. It's not for those with past bad reactions to clonazepam, olanzapine, or buprenorphine, history of substance abuse disorders within two years, current opiate addiction treatment, significant medical conditions affecting consent ability, involuntary psychiatric treatment, or suspected malingering.

What is being tested?

The trial compares three medication strategies (clonazepam alone; clonazepam with olanzapine; and all three drugs together) against standard care over a short period. The goal is to see which method best reduces acute emotional distress symptoms associated with Suicide Crisis Syndrome immediately after treatment and one month later.

What are the potential side effects?

Possible side effects include drowsiness from clonazepam; weight gain and sleepiness from olanzapine; and nausea or potential dependency issues from buprenorphine. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was admitted to the hospital within the last 36 hours.

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I am willing to stay in the hospital for at least 4 days if needed after joining the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking clonazepam or olanzapine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 month follow up after discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 month follow up after discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month follow up after discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Suicide Crisis Syndrome-Checklist (SCS-C)

Secondary study objectives

Suicide Crisis Inventory-Short Form (SCI-SF) for Severity

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: T arm: Three-drug combination clonazepam/olanzapine/buprenorphineExperimental Treatment3 Interventions

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 II: S arm: Single drug clonazepamExperimental Treatment1 Intervention

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

Group III: D arm: Two-drug combination clonazepam/olanzapineExperimental Treatment2 Interventions

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 IV: Control GroupActive Control1 Intervention

Participants that will not receive an intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olanzapine

2005

Completed Phase 4

~5480

Buprenorphine

2014