Psychopharmacological Treatment of Emotional Distress

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06133114
Phase
PHASE4
Status
Recruiting
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Conditions

  • Psychological Distress
  • Suicide Crisis Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clonazepam — DRUG
    0.5 mg twice a day (1 mg a day)
  • Olanzapine — DRUG
    2.5 mg once a day of Olanzapine
  • Buprenorphine — DRUG
    2 mg once a day of Buprenorphine

Study Details

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.

Key Dates

Start date
Mar 13, 2024
Status verified
Jun 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: S arm: Single drug clonazepam
    Single drug clonazepam: 1 mg a day (0.5 mg twice a day) with Treatment As Usual (TAU)
  • Experimental: 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)
  • Experimental: 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)
  • No Intervention: Control Group
    Participants that will not receive an intervention.

Primary Outcome Measure

Suicide Crisis Syndrome-Checklist (SCS-C) [ Time Frame: up to 1 month follow up after discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Martina Sobrero, MD
[email protected]
Rawad El Hayek, MD
[email protected]
Igor Galynker (PRINCIPAL_INVESTIGATOR)

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