RECRUITING

Psychopharmacological Treatment of Emotional Distress

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial

Quick Facts

Study Start:2024-03-13
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06133114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient admitted to an inpatient unit and ruled in for SCS diagnosis using SCS-C
  2. * Willing to stay in the hospital voluntarily, if medically necessary, for at least 4 days after enrolling in the study.
  3. * 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).
  4. * Admitted to an inpatient unit in the last 36 hrs.
  5. * Able to understand the nature and the substance of the consent form.
  6. * Currently domiciled.
  7. * Able and willing to provide verifiable contact information for follow-up.
  1. * Intellectual disability, cognitive impairment, or linguistic limitation precluding understanding of the consent or research questions.
  2. * Past adverse reactions to clonazepam, olanzapine, or buprenorphine
  3. * Past history of opiate or benzodiazepine use d/o in the last 2 years
  4. * On agonist therapy for opiate addiction
  5. * Ongoing treatment with clonazepam or olanzapine.
  6. * Significant medical or neurological disease or possible delirium that might interfere with study participation or capacity to provide informed consent.
  7. * Receiving involuntary treatment in psychiatric unit
  8. * Clinical suspicion of malingering by a CP.
  9. * Undomiciled.

Contacts and Locations

Study Contact

Igor Galynker, MD,PhD
CONTACT
212 420 4535
igor.galynker@mountsinai.org

Principal Investigator

Igor Galynker, MD,PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Igor Galynker, MD,PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-13
Study Completion Date2026-10

Study Record Updates

Study Start Date2024-03-13
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Suicide Crisis Syndrome
  • Psychological Distress