Social Anxiety Disorder (SAD)Phase 4NCT07799493
Caplyta Versus Placebo for Adults With Social Anxiety Disorder
A Phase 4 study testing Lumateperone 42 mg in people with Social Anxiety Disorder (SAD), run by Jason Careri at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder (SAD)
- What is being tested?
- Lumateperone 42 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to 28 May 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Any history of seizure or seizure disorder, with the exception of a single childhood febrile seizure.
- Any current unstable and/or clinically significant medical condition, based on history or as evidenced in screening laboratory results or ECG assessments.
- Subjects with known hypersensitivity or allergy to lumateperone, or for whom Caplyta® is otherwise contraindicated.
- Subjects receiving a moderate or strong CYP3A4 inhibitor, or any CYP3A4 inducer.
- Subjects receiving fluoxetine within 28 days of Baseline.
- Subjects receiving a MAO inhibitor within 14 days of the Baseline visit.
- 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.
- 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.
- Subjects who have received any electroconvulsive therapy (ECT) within 12 weeks of Baseline.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
IMA Clinical Research
New York, New York, 10128
Ann Draine, 212-595-5012, ann.draine@imaresearch.com
About this study
Official title: 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
- Conditions
- Social Anxiety Disorder (SAD)
- Being tested
- Lumateperone 42 mg, Placebo
- Keywords
- SAD, Social Anxiety, Social Phobia
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumateperone 42 mgDrug
Lumateperone (Caplyta) 42 mg daily for adults with Social Anxiety Disorder
PlaceboDrug
Matching placebo for lumateperone (Caplyta) 42 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo for 42 mg lumateperone (Caplyta) Receives: Drug: Placebo |
| Caplyta | Experimental | Caplyta 42mg per day Receives: Drug: Lumateperone 42 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to study endpoint (Week 8 or Last Observation Carried Forward (LOCF))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start10 Sep 2026
- Primary completion18 May 2028 (estimated)
- Study completion28 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety Disorder (SAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jason Careri
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Jason Careri, IMA Clinical Research
- Investigators
- Jason Careri, MD, Principal investigator, IMA Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799493
- Sponsor's protocol ID
- CAP-MRN-S40
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plans to share IPD.