← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month follow up after discharge

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Suicide Crisis Syndrome-Checklist (SCS-C)

Secondary outcome measures

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

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

Completed Phase 4

~2600

Clonazepam

2024

Completed Phase 4

~1290

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

861 Previous Clinical Trials

525,196 Total Patients Enrolled

Igor Galynker, MD,PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How perilous is the administration of single-drug clonazepam to individuals?

"Drawing on our research, we have assigned S arm: Single drug clonazepam a safety rating of 3. This reflects the fact that this therapeutic intervention is approved for use and has passed Phase 4 clinical trials."

Answered by AI

Does this research still have open slots for participants?

"The latest updates on clinicaltrials.gov indicate that this trial, whose first posting was dated November 1st 2023, is not actively seeking participants at the moment. However, there are 253 other ongoing studies which may be worth investigating."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Psychopharmacological Treatment of Emotional Distress

Igor Galynker 2024. "Psychopharmacological Treatment of Emotional Distress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06133114.

All > Probuphine