Caplyta Versus Placebo for Adults With Social Anxiety Disorder

Caplyta® in the Treatment of Social Anxiety Disorder: A Double-Blind Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Social Anxiety Disorder (SAD)
• Intervention / Treatment: Drug: Placebo; Drug: Lumateperone 42 mg

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ann Draine; Phone Number: 212-595-5012; Email: ann.draine@imaresearch.com
• Study Contact Backup: Name: Brittany Smith; Phone Number: 212-595-5012; Email: brittany.smith@imaresearch.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • IMA Clinical Research
      • Contact: Ann Draine; Phone Number: 212-595-5012; Email: ann.draine@imaresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female adults between 18 and 65 years of age (inclusive).
2. Written informed consent given prior to any study procedures.
3. 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.
4. Minimum total score of 70 on the LSAS at Screening and Baseline visits.
5. Total Hamilton Depression Rating Scale (HAM-D) score of less than 16 at Screening and Baseline.
6. Clinical Global Impression of Severity (CGI-S) score of 4 or greater at Screening and Baseline.
7. 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.

Exclusion Criteria:

1. 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

2. 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.

3. Subjects with any history or complication of schizophrenia or bipolar disorder.
4. Subjects with a complication of body dysmorphic disorder.

5. 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

6. Substance use disorder, as defined by DSM-5 criteria, within 24 weeks of Baseline.
7. Positive Urine Drug Screen at Baseline, unless due to prescribed medication.
8. Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95, as measured at Screening and Baseline visits.
9. Current diagnosis of Diabetes Mellitus (type 1 or 2).
10. Current diagnosis or past history of significant cardiovascular disease.

11. 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.

12. Subjects with a history or complication of cancer or malignant tumor not in remission for at least 5 years. Basal cell skin cancers are not exclusionary.
13. Any history of seizure or seizure disorder, with the exception of a single childhood febrile seizure.
14. Any current unstable and/or clinically significant medical condition, based on history or as evidenced in screening laboratory results or ECG assessments.
15. Subjects with known hypersensitivity or allergy to lumateperone, or for whom Caplyta® is otherwise contraindicated.
16. Subjects receiving a moderate or strong CYP3A4 inhibitor, or any CYP3A4 inducer.
17. Subjects receiving fluoxetine within 28 days of Baseline.
18. Subjects receiving a MAO inhibitor within 14 days of the Baseline visit.

19. Subjects receiving any other psychotropics within 14 days of Baseline (including but not limited to: gabapentin, pregabalin, antipsychotics, SSRIs, SNRIs, benzodiazepines, and sedative hypnotics other than zolpidem).

    Zolpidem (Ambien®) PRN is allowed for insomnia, if not taken more than 3 times per week.

    Subjects on a stable dose of a beta-blocker for hypertension (stable for at least six months prior to Baseline) are not excluded from study participation.

20. Subjects who started psychotherapy or Cognitive Behavioral Therapy (CBT) within 24 weeks of Screening, except for supportive psychotherapy.

    Subjects who have been receiving psychotherapy or CBT for more than 24 weeks prior to Screening are eligible for the study, provided that the therapy continues at the same frequency for the duration of the trial.

21. Subjects who have received any electroconvulsive therapy (ECT) within 12 weeks of Baseline.
22. Subjects who are currently pregnant, lactating, or of childbearing potential and not able and willing to practice an effective method of contraception for the duration of the trial and at least 4 weeks after the final study visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo for 42 mg lumateperone (Caplyta)	Drug: Placebo; Matching placebo for lumateperone (Caplyta) 42 mg
Experimental: Caplyta; Caplyta 42mg per day	Drug: Lumateperone 42 mg; Lumateperone (Caplyta) 42 mg daily for adults with Social Anxiety Disorder

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jason Careri
• Investigators: Principal Investigator: Jason Careri, MD, IMA Clinical Research

Study record dates

Study Major Dates

• Study Start (Estimated): August 18, 2026
• Primary Completion (Estimated): May 18, 2028
• Study Completion (Estimated): May 28, 2028

Study Registration Dates

• First Submitted: August 28, 2026
• First Submitted That Met QC Criteria: August 28, 2026
• First Posted (Actual): September 2, 2026

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 28, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Social Anxiety; Social Phobia; SAD
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; lumateperone
• Other Study ID Numbers: CAP-MRN-S40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plans to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes