ClinicalTrials.gg
CompletedNCT02432703Updated Apr 29, 2025Results posted

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

A Phase 2 interventional study of JNJ-42165279 and Placebo in Phobic Disorders, sponsored by Janssen Research & Development, LLC. Completed at 21 sites in 3 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-04-29.

Primary conditionPhobia, SocialRegistry: Phobic DisordersReclassifiedWhy we changed it
Registry
Phobic Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Phobia, Social
Why
  1. The study's title name Phobia, Social, a narrower term within Phobic Disorders.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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).

Read the detailed description

This is a Phase 2a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participants know about the study intervention), placebo-controlled, parallel-group, multi-center study of JNJ-42165279 in participants with social anxiety disorder. Participants will receive 25 milligram (mg) JNJ-42165279 or matching placebo orally once-daily from Day 1 up to 12 weeks. Participants will primarily be assessed for the change from baseline in Liebowitz Social Anxiety Scale (LSAS) at Week 12. Safety will be monitored throughout the study.

02

Conditions studied

  • Phobic Disorders

Browse trials for

Keywords

  • Social Anxiety Disorder
  • JNJ-42165279
03

In context

Phobia, Social Reclassified

367 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.

This study's enrollment of 150 is above the median of 76 across 338 interventional studies indexed under Phobia, Social.

Browse Phobia, Social studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.

Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.

Compared within Phobia, Social, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Phobic Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must have a primary 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 (BMI) between 18 and 35 kilogram per meter square (kg/m\^2), inclusive, at screening
  • Female participants must be either or surgically sterile

Exclusion criteria

Exclusion Criteria:

  • Participants who have performance only SAD are excluded. Participants with other current significant psychiatric condition(s) (Axis 1 under ), 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    JNJ-42165279

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

    Drug: JNJ-42165279

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline and Week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 12

  2. 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.

    Time frame: Week 12

  3. 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.

    Time frame: Week 12

  4. 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.

    Time frame: Baseline and Week 12

  5. 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.

    Time frame: Baseline and Week 12

  6. 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.

    Time frame: Baseline and Week 12

  7. 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.

    Time frame: Baseline and Week 12

  8. 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.

    Time frame: Baseline and Week 12

  9. 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.

    Time frame: Week 12

  10. 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.

    Time frame: Baseline, Week 12

07

Results

Posted Sep 2, 2021
Limitations and caveats
The US food and drug administration placed a clinical hold on studies being conducted with fatty acid amide hydrolase (FAAH) inhibitor. When determined that serious adverse events were not related to FAAH inhibition, Janssen resumed this study in December 2016. At time of study suspension, an unblinded safety analysis was performed, and hence sample size was increased to replace participants who withdrew due to study suspension. Planned analyses were performed at time of final database lock.

Participant flow

Participant flow — Overall Study
MilestonePlaceboJNJ-42165279 25 mg
Started7574
Completed5356
Not completed2218
Withdrew: Adverse event14
Withdrew: Lack of efficacy10
Withdrew: Lost to follow-up53
Withdrew: Withdrawal by subject96
Withdrew: Other65

Outcome measures

PrimaryChange 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).

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score
units on a scalePlaceboJNJ-42165279 25 mg
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score-22.4 ± 23.57-29.4 ± 27.47
SecondaryChange 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales
units on a scalePlaceboJNJ-42165279 25 mg
Fear/Anxiety-10.7 ± 12.31-14.6 ± 13.65
Avoidance-11.7 ± 12.16-14.9 ± 14.45
SecondaryPercentage 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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score
percentage of participantsPlaceboJNJ-42165279 25 mg
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score12.718.6
SecondaryPercentage 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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score
percentage of participantsPlaceboJNJ-42165279 25 mg
Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score23.642.4
SecondaryChange 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score
units on a scalePlaceboJNJ-42165279 25 mg
Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score-3.0 ± 6.20-4.2 ± 5.90
SecondaryChange 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score
units on a scalePlaceboJNJ-42165279 25 mg
Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score-1.9 ± 3.32-2.3 ± 3.79
SecondaryChange 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline in Hamilton Depression Rating Scale (HDRS)-17 Total Score
units on a scalePlaceboJNJ-42165279 25 mg
Change From Baseline in Hamilton Depression Rating Scale (HDRS)-17 Total Score-0.9 ± 4.71-1.8 ± 3.99
SecondaryChange 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score
units on a scalePlaceboJNJ-42165279 25 mg
Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score-0.4 ± 2.25-0.9 ± 2.05
SecondaryChange 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.

Time frame:
Baseline and Week 12
Reported as:
Mean · units on a scale
Change From Baseline in HAM-D6 Total Score
units on a scalePlaceboJNJ-42165279 25 mg
Change From Baseline in HAM-D6 Total Score-0.7 ± 2.89-1.0 ± 2.56
SecondaryPercentage 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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Change From Baseline in Clinical Global Impression- Improvement (CGI-I) Score
percentage of participantsPlaceboJNJ-42165279 25 mg
Very much improved or much improved23.644.1
Worsening or no change45.535.6
SecondaryPercentage 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.

Time frame:
Baseline, Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With >=50% Improvement From Baseline (Responders) in SIGH-A Total Score
percentage of participantsPlaceboJNJ-42165279 25 mg
Percentage of Participants With >=50% Improvement From Baseline (Responders) in SIGH-A Total Score47.345.6

Adverse events

Collected over Up to 20 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/75 (0%)0/75 (0%)27/75 (36%)
JNJ-42165279 25 mg0/74 (0%)2/74 (2.7%)26/74 (35.1%)
Most frequent serious events
Most frequent serious events
EventPlaceboJNJ-42165279 25 mg
Anaphylactic ReactionImmune system disorders0/751/74
Alcohol Use DisorderPsychiatric disorders0/751/74
Most frequent other events
Most frequent other events
EventPlaceboJNJ-42165279 25 mg
HeadacheNervous system disorders13/7515/74
FatigueGeneral disorders3/756/74
NasopharyngitisInfections and infestations6/754/74
InsomniaPsychiatric disorders6/751/74
DiarrhoeaGastrointestinal disorders2/755/74
Upper Respiratory Tract InfectionInfections and infestations3/755/74
NauseaGastrointestinal disorders4/750/74

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboJNJ-42165279 25 mgTotal
Mean37.4 ± 13.6538.3 ± 12.5337.8 ± 13.07
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboJNJ-42165279 25 mgTotal
Female262652
Male494897
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboJNJ-42165279 25 mgTotal
Hispanic or Latino91322
Not Hispanic or Latino6661127
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboJNJ-42165279 25 mgTotal
American Indian or Alaska Native000
Asian8412
Native Hawaiian or Other Pacific Islander000
Black or African American151833
White455095
More than one race213
Unknown or Not Reported516
Region of Enrollment
Region of Enrollment(Participants)PlaceboJNJ-42165279 25 mgTotal
AUSTRALIA111223
CANADA141226
UNITED STATES5050100
08

Study locations

21 sites
  • La Jolla, California, United States
  • Hartford, Connecticut, United States
  • Orlando, Florida, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Natick, Massachusetts, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Staten Island, New York, United States
  • Allentown, Pennsylvania, United States
  • Reading, Pennsylvania, United States
  • Dallas, Texas, United States
  • Salt Lake City, Utah, United States
  • Adelaide, Australia
  • Frankston, Australia
  • Melbourne, Australia
  • Perth, Australia
  • Edmonton, Alberta, Canada
  • Hamilton, Ontario, Canada
  • Mississauga, Ontario, Canada
  • Toronto, Ontario, Canada
09

References and documents

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. PubMed 33070154 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02432703
Responsible party
Sponsor
First posted
May 4, 2015
Start date
Jun 11, 2015
Primary completion
Aug 9, 2018
Completion
Aug 9, 2018
Results posted
Sep 2, 2021
Last update
Apr 29, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: JNJ-42165279

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