Recruiting PHASE4 Suicide Crisis Syndrome

New treatment option for Suicide Crisis Syndrome

Official title Psychopharmacological Treatment of Emotional Distress

ClinicalTrials.gov ID: NCT06133114

What this study is testing

What is Clonazepam?

Clonazepam is an investigational medicine, given as a twice-daily, being studied as a potential treatment for suicide crisis syndrome.

Also referred to as TAU.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • Admitted to an inpatient unit in the last 36 hrs.
  • Able to understand the nature and the substance of the consent form.

You likely can't join if

  • 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...
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • New York, New York, United States

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.