Caplyta Versus Placebo for Adults With Social Anxiety Disorder
ConditionSocial Anxiety Disorder (SAD)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJason Careri
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 any history or complication of schizophrenia or bipolar disorder.
Subjects with a complication of body dysmorphic disorder.
Substance use disorder, as defined by DSM-5 criteria, within 24 weeks of Baseline.
Trial design
Design model
Parallel
Treatments tested in this trial
Lumateperone 42 mg
DrugLumateperone (Caplyta) 42 mg daily for adults with Social Anxiety Disorder
Placebo
DrugMatching placebo for lumateperone (Caplyta) 42 mg
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: CaplytaExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to study endpoint (Week 8 or Last Observation Carried Forward (LOCF))Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jason Careri
Lead sponsor
IMA Clinical Research
Sponsor institution
Source ClinicalTrials.gov