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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02432703




Registration number
NCT02432703
Ethics application status
Date submitted
29/04/2015
Date registered
4/05/2015
Date last updated
2/09/2021

Titles & IDs
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.
Secondary ID [1] 0 0
42165279SAX2001
Secondary ID [2] 0 0
CR106641
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phobic Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-42165279
Treatment: Drugs - Placebo

Experimental: JNJ-42165279 - Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.

Placebo Comparator: Placebo - Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.


Treatment: Drugs: JNJ-42165279
Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.

Treatment: Drugs: Placebo
Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score - The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually) with higher scores indicating greater social anxiety. The LSAS fear/anxiety and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of social anxiety disorder (SAD).
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales - The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually). Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of SAD. The LSAS fear/anxiety and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72.
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score - Responders are participants with >= 50% improvement from baseline. The LSAS scale consists of 24 items which are divided into 2 subscales that address social interactional (11 items) and performance (13 items) situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually) with higher scores indicating greater social anxiety. The LSAS fear and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of SAD.
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score - Remitters are participants with >= 30% improvement from baseline on LSAS total score. The LSAS scale consists of 24 items which are divided into 2 subscales that address social interactional (11 items) and performance (13 items) situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually) with higher scores indicating greater social anxiety. The LSAS fear and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of SAD.
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score - The SIGH-A was included to determine the frequency and severity of signs and symptoms of anxiety, including participants with comorbid generalized anxiety disorders (GAD) and major depressive disorder (MDD), and determine both their influence on treatment and their responsiveness to treatment. The SIGH-A scale consists of 14 items with a score of 0 to 4. Higher scores indicated higher severity (0-absent, 1-mild, 2-moderate, 3-severe, 4-incapacitating). The SIGH-A total score was calculated by summing the 14 item scores, and ranges from 0 to 56. Higher scores indicated worse results.
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score - The HAM-A6 is a 6-item subscale derived from the original Hamilton Anxiety scale (HAM-A). It comprises of five psychic anxiety symptoms: anxious mood, psychic tension, fears, intellectual disturbances, and anxious behavior observed at the interview, as well as one somatic item, muscular tension. Each of the 6 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree). The HAM-A6 score was calculated by summing the 6 item scores, and ranges from 0 to 24. Higher scores indicated greater severity of symptoms.
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Change From Baseline in Hamilton Depression Rating Scale (HDRS)-17 Total Score - The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition.
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score - The HDRS17 anxiety/somatization factor derived from Cleary and Guy's factor analysis of the HDRS17 scale, includes six items from the original 17-item version: the items for psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. Each of these items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). HDRS17 anxiety/somatization factor total score was calculated as the sum of the 6 item scores ranging from 0 to 18. Higher scores indicated greater severity of symptoms.
Timepoint [7] 0 0
Baseline and Week 12
Secondary outcome [8] 0 0
Change From Baseline in HAM-D6 Total Score - A 6-item subscale from the HDRS17 (HAM-D6) was analyzed as it had been shown to be a uni-dimensional scale that provided information to core depressive symptoms and was sensitive to treatment response. The six items were: depressed mood, guilt feelings, work and interests, psychomotor retardation, psychic anxiety, and general somatics (tiredness and pains). Each of these items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). General somatics is scored 0 to 2 and all others are scored 0 to 4. The HAM-D6 total score was calculated by summing the 6 items scores, and ranges from 0 to 22. Higher scores indicated greater severity of core symptoms.
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Percentage of Participants With Change From Baseline in Clinical Global Impression- Improvement (CGI-I) Score - The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The CGI-I is rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Percentage of participants with change from baseline (very much improved or much improved and Worsening or no change) in CGI-I score were reported.
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Percentage of Participants With >=50% Improvement From Baseline (Responders) in SIGH-A Total Score - Responders are participants with >= 50% improvement from baseline in SIGH-A total score. The SIGH-A scale consists of 14 items with a score of 0 to 4. Higher scores indicated higher severity (0-absent, 1-mild, 2-moderate, 3 severe, 4-incapacitating). The SIGH-A total score was calculated by summing the 14 item scores, and ranges from 0 to 56. Higher scores indicated worse results.
Timepoint [10] 0 0
Baseline, Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Frankston
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Frankston
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate the efficacy of JNJ-42165279 during 12 weeks of
treatment in participants with Social Anxiety Disorder (SAD).
Trial website
https://clinicaltrials.gov/show/NCT02432703
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications