Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT04221997
Phase
PHASE4
Status
Recruiting
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Conditions

  • Anxiety Disorders

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • sertraline — DRUG
    Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)

Study Details

A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.

Key Dates

Start date
Nov 1, 2019
Status verified
Oct 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: sertraline
    90 patients will be randomized to sertraline
  • Placebo Comparator: Placebo
    30 patient will be randomized to placebo
  • No Intervention: Healthy Control
    30 healthy comparison subjects will be followed over the course of 12 weeks

Primary Outcome Measure

Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2 [ Time Frame: Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45219
Heidi K Schroeder, BS
[email protected]
513-558-4422
Jeffrey R Strawn, MD (PRINCIPAL_INVESTIGATOR)

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