MedTrace Logo

Caplyta Versus Placebo for Adults With Social Anxiety Disorder

NCT07799493 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-09-02

No results posted yet for this study

Summary

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

Conditions

  • Social Anxiety Disorder (SAD)

Interventions

DRUG

Lumateperone 42 mg

Lumateperone (Caplyta) 42 mg daily for adults with Social Anxiety Disorder

DRUG

Placebo

Matching placebo for lumateperone (Caplyta) 42 mg

Sponsors & Collaborators

  • Jason Careri

    lead NETWORK

Principal Investigators

  • Jason Careri, MD · IMA Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-18
Primary Completion
2028-05-18
Completion
2028-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07799493 on ClinicalTrials.gov