Caplyta Versus Placebo for Adults With Social Anxiety Disorder

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

Sponsor
Jason Careri
Study ID
NCT07799493
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Social Anxiety Disorder (SAD)

Eligibility Criteria

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

Interventions

  • Lumateperone 42 mg — DRUG
    Lumateperone (Caplyta) 42 mg daily for adults with Social Anxiety Disorder
  • Placebo — DRUG
    Matching placebo for lumateperone (Caplyta) 42 mg

Study Details

The goal of this clinical trial is to learn if Caplyta works to treat Social Anxiety Disorder in adults. The main question it aims to answer is: Does Caplyta lower the frequency/severity of social anxiety symptoms in adults? Researchers will compare Caplyta to a placebo (a look-alike substance that contains no drug) to see if Caplyta works to treat Social Anxiety Disorder. Participants will: Take Caplyta or a placebo every day for 8 weeks Visit the clinic once every week for checkups and tests

Key Dates

First listed
Sep 2, 2026
Start date
Aug 18, 2026
Status verified
Aug 2026
Primary completion
May 18, 2028
Completion
May 28, 2028

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Matching placebo for 42 mg lumateperone (Caplyta)
  • Experimental: Caplyta
    Caplyta 42mg per day

Primary Outcome Measure

Change in total LSAS score from Baseline to study endpoint [ Time Frame: Baseline to study endpoint (Week 8 or Last Observation Carried Forward (LOCF)) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
IMA Clinical ResearchNew YorkNew York10128
Ann Draine
[email protected]
212-595-5012

Find similar trials in New York, NY

By research site
IMA Clinical Research· New York, NY

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