A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02432703
• Date of registration: 29/04/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder
• Scientific title: A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-42165279 in Subjects With Social Anxiety Disorder.
• Date of first enrolment: June 15, 2015
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02432703
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must have a primary DSM-5 diagnosis of Social anxiety disorder (SAD) except those with
performance only as a specifier. Participants with a diagnosis of comorbid Generalized
Anxiety Disorder (GAD) or Major Depressive Disorder (MDD) may be included if the
Investigator considers SAD to be the predominant diagnosis. Participants with current
or lifetime history of Attention deficit hyperactivity disorder (ADHD) and specific
phobia may be included as well

- Must have a Liebowitz Social Anxiety Scale score greater than or equal (>=) 70 at
Screening and Baseline

- Participants with a current episode of MDD must have a HDRS17 total score less than or
equal to (<=) 18

- Must have a body mass index (BMI) between 18 and 35 kilogram per meter square
(kg/m^2), inclusive, at screening

- Female participants must be either postmenopausal or surgically sterile

Exclusion Criteria:

- Participants who have performance only SAD are excluded. Participants with other
current significant psychiatric condition(s) (Axis 1 under DSM-IV), including, but not
limited to, MDD with psychotic features (lifetime), bipolar disorder (including
lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder,
eating disorder (e.g., bulimia, anorexia nervosa), autism spectrum disorders,
post-traumatic stress disorder (PTSD) or schizophrenia are excluded. Participants with
a diagnosis of comorbid GAD or MDD may be included

- Participants is currently receiving specific psychotherapy for SAD

- Has a history of more than two unsuccessful adequate pharmacological treatment trials
for SAD, defined as lack of response to at least 10 weeks of treatment at adequate
doses (e.g., paroxetine >= 40 milligram per day (mg/day) or its equivalent; or
clonazepam >= 2.5 mg/day or its equivalent)

- Concurrent use of psychotropic medications

- has a history of or current thyroid disease, thyroid dysfunction and is currently
untreated for it



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Phobic Disorders

Intervention(s)

Drug: JNJ-42165279

Drug: Placebo

Primary Outcome(s)

Change From Baseline in the Liebowitz Social Anxiety Scale (LSAS) Total Score at Week 12 [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Change from Baseline in Hamilton Anxiety Rating scale (HAM-A6) Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Fear/Anxiety and Avoidance Subscales at Week 12 [Time Frame: Baseline and Week 12]

Change from Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score at Week 12 [Time Frame: Baseline and Week 12]

Percentage of Participants who are Responders and Remitters on Liebowitz Social Anxiety Scale (LSAS) Total Score at Week 12 [Time Frame: Baseline and Week 12]

Number of Participants who are Responders on SIGH-A Total Score at Week 12 [Time Frame: Baseline and Week 12]

Change from Baseline in Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Total Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in 6-Item Hamilton Depression Scale (HAM-D6) Score at Week 12 [Time Frame: Baseline and Week 12]

Number of Participants who are Responders and Remitters on Liebowitz Social Anxiety Scale (LSAS) Total Score at Week 12 [Time Frame: Baseline and Week 12]

Clinical Global Impression - Improvement (CGI-I) Score From Baseline at Week 12 [Time Frame: Baseline and Week 12]

Percentage of Participants who are Responders on SIGH-A Total Score at Week 12 [Time Frame: Baseline and Week 12]

Secondary ID(s)

2014-004258-32

42165279SAX2001

CR106641

Source(s) of Monetary Support

Please refer to primary and secondary sponsors