Cariprazine Versus Placebo for Social Anxiety Disorder

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

Sponsor
The Medical Research Network
Study ID
NCT05384483
Phase
PHASE4
Status
Completed

Conditions

  • Social Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine — DRUG
    Cariprazine 1.5 to 3 mg per day
  • Placebo — DRUG
    Matching placebo

Study Details

The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® (cariprazine) in the treatment of patients with Social Anxiety Disorder (SAD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Subjects will be randomized to one of two treatment arms (placebo or Vraylar® 1.5 mg/day) in a 1:1 ratio. The study will be done at a single clinical research site.

Key Dates

Start date
Jul 18, 2022
Status verified
Aug 2024
Primary completion
Apr 4, 2024
Completion
Apr 15, 2024

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cariprazine
    Cariprazine 1.5 to 3 mg per day
  • Placebo Comparator: Placebo
    Matching placebo

Primary Outcome Measure

Change in LSAS Score [ Time Frame: 12 Weeks or LOCF ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Medical Research Network, LLCNew YorkNew York10128-

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