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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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.
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Secondary ID [1]
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42165279SAX2001
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Secondary ID [2]
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CR106641
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Phobic Disorders
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Condition category
Condition code
Mental Health
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Anxiety
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [1]
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Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score
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Assessment method [2]
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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.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score
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Assessment method [3]
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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.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and Week 12
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Secondary outcome [5]
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Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and Week 12
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Secondary outcome [6]
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Change From Baseline in Hamilton Depression Rating Scale (HDRS)-17 Total Score
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and Week 12
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Secondary outcome [7]
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Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline and Week 12
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Secondary outcome [8]
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Change From Baseline in HAM-D6 Total Score
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline and Week 12
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Secondary outcome [9]
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Percentage of Participants With Change From Baseline in Clinical Global Impression- Improvement (CGI-I) Score
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Assessment method [9]
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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.
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Percentage of Participants With >=50% Improvement From Baseline (Responders) in SIGH-A Total Score
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline, Week 12
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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
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Minimum age
18
Years
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Maximum age
64
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/08/2018
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Sample size
Target
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Accrual to date
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Final
150
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Frankston
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Recruitment hospital [3]
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- Melbourne
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Recruitment hospital [4]
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- Perth
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Frankston
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Recruitment postcode(s) [3]
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- Melbourne
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Recruitment postcode(s) [4]
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- Perth
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Illinois
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Massachusetts
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New York
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Pennsylvania
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United States of America
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Texas
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United States of America
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Utah
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Canada
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Alberta
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Canada
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State/province [11]
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Ontario
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/study/NCT02432703
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Trial related presentations / publications
Schmidt ME, Liebowitz MR, Stein MB, Grunfeld J, Van Hove I, Simmons WK, Van Der Ark P, Palmer JA, Saad ZS, Pemberton DJ, Van Nueten L, Drevets WC. The effects of inhibition of fatty acid amide hydrolase (FAAH) by JNJ-42165279 in social anxiety disorder: a double-blind, randomized, placebo-controlled proof-of-concept study. Neuropsychopharmacology. 2021 Apr;46(5):1004-1010. doi: 10.1038/s41386-020-00888-1. Epub 2020 Oct 18.
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/03/NCT02432703/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/03/NCT02432703/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02432703
Download to PDF