Cariprazine Versus Placebo for Social Anxiety Disorder

NCT05384483 | Completed Phase 4 FDA Drug

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

Brief Summary

The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® (cariprazine) in the treatment of patients with Social Anxiety Disorder (SAD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Subjects will be randomized to one of two treatment arms (placebo or Vraylar® 1.5 mg/day) in a 1:1 ratio. The study will be done at a single clinical research site.

Conditions

Social Anxiety Disorder

Keywords

SAD; Social Anxiety; Social Phobia; Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Change in LSAS Score

  The primary outcome measure is the change in the Liebowitz Social Anxiety Score from Baseline to study endpoint (Week 12 or Last Observation Carried Forward (LOCF))

  12 Weeks or LOCF

Study Arms (2)

Cariprazine

EXPERIMENTAL

Cariprazine 1.5 to 3 mg per day

Drug: Cariprazine

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Cariprazine DRUG

Cariprazine 1.5 to 3 mg per day

Also known as: Vraylar®

Cariprazine

Placebo DRUG

Matching placebo

Placebo

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).
• Subjects must give written informed consent prior to any study procedures.
• Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Anxiety Disorder) according to DSM-5 criteria, as determined by psychiatric evaluation with the Investigator and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
• Subjects must have a minimum total score of 70 on the LSAS at both Screening and Baseline visits.
• Subjects must have a total Hamilton Depression Rating Scale (HAM-D) score of less than 16 at the Screening and Baseline visits.
• Subjects must have a Clinical Global Impression of Severity (CGI-S) score of 4 or greater at both Screening and Baseline visits.
• 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 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 Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), dysthymia, or specific phobias will 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.
• Substance use disorder, as defined by DSM-5 criteria, within 24 weeks of the Baseline visit.
• 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.
• Subjects scoring \>2 on item #3 of the HAM-D at Baseline, or who, in the opinion of the PI, are at a clinically significant risk for suicide.
• Significant risk for suicidal behavior during the course of study participation, in the opinion of the investigator, or 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 Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or Baseline, or any suicide attempt within the 6 months prior to screening.
• Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95, as measured at Screening and Baseline visits.
• Positive Urine Drug Screen at the Baseline visit, unless due to prescribed medication.
• Any current unstable and/or clinically significant medical condition, based on history or as evidenced in screening laboratory or ECG assessments.
• Current diagnosis of Diabetes Mellitus (type 1 or 2).
• Current diagnosis or past history of significant cardiovascular disease.
• Screening laboratory results showing: transaminases (ALT or AST) greater than 2 times the upper limit of normal (ULN) at screening, absolute neutrophil count (ANC) \< 1000 at screening, or active Hepatitis B or Hepatitis C.
• Any history of seizure or seizure disorder, with the exception of a single childhood febrile seizure.
• Subjects for whom cariprazine is contraindicated.

Sponsors & Collaborators

• The Medical Research Network: lead
• AbbVie: collaborator

Study Sites (1)

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Michael R Liebowitz, MD

  Managing Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: July 18, 2022
• Primary Completion: April 4, 2024
• Study Completion: April 15, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)