Caplyta Versus Placebo for Adults With Social Anxiety Disorder

NCT07799493 | Recruiting Phase 4 FDA Drug

• 1 other identifier: CAP-MRN-S40
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

SAD; Social Anxiety; Social Phobia

Outcome Measures

Primary Outcomes (1)

• Change in total Liebowitz Social Anxiety Scale (LSAS) score from Baseline to study endpoint

  LSAS scores range from 0 (no anxiety) to 144 (very severe social anxiety). The LSAS consists of 24 items, each representing a different performance or social situation. Each item/situation is scored for fear/anxiety and for avoidance, each on a scale of 0 to 3, with 0 representing no anxiety/avoidance, and 3 representing severe anxiety/avoidance.

  Baseline to study endpoint (Week 8 or Last Observation Carried Forward (LOCF))

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching placebo for 42 mg lumateperone (Caplyta)

Drug: Placebo

Caplyta

EXPERIMENTAL

Caplyta 42mg per day

Drug: Lumateperone 42 mg

Interventions

Placebo DRUG

Matching placebo for lumateperone (Caplyta) 42 mg

Placebo

Lumateperone 42 mg DRUG

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

Caplyta

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults between 18 and 65 years of age (inclusive).
• Written informed consent given prior to any study procedures.
• Diagnosis of Social Anxiety Disorder (SAD) according to DSM-5 criteria, as determined by psychiatric evaluation with the Investigator and as confirmed by the MINI at Screening.
• Minimum total score of 70 on the LSAS at Screening and Baseline visits.
• Total Hamilton Depression Rating Scale (HAM-D) score of less than 16 at Screening and Baseline.
• Clinical Global Impression of Severity (CGI-S) score of 4 or greater at Screening and Baseline.
• All subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial and for at least 4 weeks after it ends.
• Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices.
• Abstinence from heterosexual intercourse will also be considered an effective form of contraception, if abstinence is part of the subject's usual lifestyle.

You may not qualify if:

• Subjects with a history of treatment refractory SAD, defined for this study as: a history of two or more failed treatment trials, with an FDA-approved SAD treatment, whereby a treatment trial is defined as a period of at least 6 weeks during which the subject received an adequate dosage of the SAD treatment. The minimum adequate dosage of FDA-approved SAD treatments is defined as follows:
• Paxil®/paroxetine: 20 mg Zoloft®/sertraline: 100 mg Effexor XR®/venlafaxine: 150 mg Luvox®/fluvoxamine: 100 mg
• Subjects with any Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit.
• Subjects with co-morbid MDD, GAD, dysthymia, ADHD, or specific phobias may be allowed if SAD is the primary disorder in terms of clinical severity, as determined by the investigator.
• Subjects with any history or complication of schizophrenia or bipolar disorder.
• Subjects with a complication of body dysmorphic disorder.
• Subjects who are at risk of suicide, including:
• Subjects scoring \>2 on item #3 of the HAM-D at Screening or Baseline Subjects with recent (within the last 6 months prior to screening) suicidal behavior, defined as scoring "yes" on items 4 or 5 in the Suicidal Ideation section of the C-SSRS at Screening or Baseline Subjects who, in the opinion of the investigator, are at significant risk of suicide or suicidal behavior during the course of study participation Subjects with any suicide attempt within the 6 months prior to screening
• Substance use disorder, as defined by DSM-5 criteria, within 24 weeks of Baseline.
• Positive Urine Drug Screen at Baseline, unless due to prescribed medication.
• Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95, as measured at Screening and Baseline visits.
• Current diagnosis of Diabetes Mellitus (type 1 or 2).
• Current diagnosis or past history of significant cardiovascular disease.
• Current hepatic impairment, including screening laboratory results showing:
• transaminases (ALT or AST) greater than 2 times the upper limit of normal (ULN), absolute neutrophil count (ANC) \< 1000, or active Hepatitis B or Hepatitis C.

Sponsors & Collaborators

• Jason Careri: lead

Study Sites (1)

IMA Clinical Research

New York, New York, 10128, United States

RECRUITING

MeSH Terms

Conditions

Phobia, Social

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Jason Careri, MD

  IMA Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Draine

CONTACT

212-595-5012; ann.draine@imaresearch.com

Brittany Smith

CONTACT

212-595-5012; brittany.smith@imaresearch.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): May 18, 2028
• Study Completion (Estimated): May 28, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)