Trial · NCT02432703

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

NCT02432703, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2021-09-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder. Trials, record NCT02432703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02432703

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder
NCT number: NCT02432703
Status: Completed
Phases: Phase 2
Enrollment: 150 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Phobic Disorders
Interventions: JNJ-42165279, Placebo
First posted: 2015-05-04
Last updated: 2025-04-29
Other registries' IDs: eudract:2014-004258-32
Results first posted: 2021-09-02
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.

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score	Baseline and Week 12	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).
Secondary	Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales	Baseline and Week 12	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.
Secondary	Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score	Week 12	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.
Secondary	Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score	Week 12	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.
Secondary	Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score	Baseline and Week 12	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.
Secondary	Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score	Baseline and Week 12	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.
Secondary	Change From Baseline in Hamilton Depression Rating Scale (HDRS)-17 Total Score	Baseline and Week 12	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.
Secondary	Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score	Baseline and Week 12	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.
Secondary	Change From Baseline in HAM-D6 Total Score	Baseline and Week 12	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.
Secondary	Percentage of Participants With Change From Baseline in Clinical Global Impression- Improvement (CGI-I) Score	Week 12	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.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score	Baseline and Week 12	Intent-to-treat (ITT) analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.	units on a scale	MEAN
SECONDARY	Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales	Baseline and Week 12	ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.	units on a scale	MEAN
SECONDARY	Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score	Week 12	ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score	Week 12	ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score	Baseline and Week 12	ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.	units on a scale	MEAN
SECONDARY	Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score	Baseline and Week 12	ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.	units on a scale	MEAN
SECONDARY	Change From Baseline in Hamilton Depression Rating Scale (HDRS)-17 Total Score	Baseline and Week 12	ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.	units on a scale	MEAN
SECONDARY	Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score	Baseline and Week 12	ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.	units on a scale	MEAN
SECONDARY	Change From Baseline in HAM-D6 Total Score	Baseline and Week 12	ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.	units on a scale	MEAN
SECONDARY	Percentage of Participants With Change From Baseline in Clinical Global Impression- Improvement (CGI-I) Score	Week 12	All randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.	percentage of participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score	Placebo		-22.4	Standard Deviation 23.57	units on a scale
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score	JNJ-42165279 25 mg		-29.4	Standard Deviation 27.47	units on a scale
Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales	Placebo	Fear/Anxiety	-10.7	Standard Deviation 12.31	units on a scale
Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales	JNJ-42165279 25 mg	Fear/Anxiety	-14.6	Standard Deviation 13.65	units on a scale
Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales	Placebo	Avoidance	-11.7	Standard Deviation 12.16	units on a scale
Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales	JNJ-42165279 25 mg	Avoidance	-14.9	Standard Deviation 14.45	units on a scale
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score	Placebo		12.7		percentage of participants
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score	JNJ-42165279 25 mg		18.6		percentage of participants
Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score	Placebo		23.6		percentage of participants
Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score	JNJ-42165279 25 mg		42.4		percentage of participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	75
Overall Study	STARTED	JNJ-42165279 25 mg	74
Overall Study	COMPLETED	Placebo	53
Overall Study	COMPLETED	JNJ-42165279 25 mg	56
Overall Study	NOT COMPLETED	Placebo	22
Overall Study	NOT COMPLETED	JNJ-42165279 25 mg	18

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	75
other	Diarrhoea	Gastrointestinal disorders	JNJ-42165279 25 mg	5	74
other	Nausea	Gastrointestinal disorders	Placebo	4	75
other	Nausea	Gastrointestinal disorders	JNJ-42165279 25 mg	0	74
other	Fatigue	General disorders	Placebo	3	75
other	Fatigue	General disorders	JNJ-42165279 25 mg	6	74
other	Nasopharyngitis	Infections and infestations	Placebo	6	75
other	Nasopharyngitis	Infections and infestations	JNJ-42165279 25 mg	4	74
other	Upper Respiratory Tract Infection	Infections and infestations	Placebo	3	75
other	Upper Respiratory Tract Infection	Infections and infestations	JNJ-42165279 25 mg	5	74

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	75
Total, all-cause mortality	JNJ-42165279 25 mg	0	74
Total, other adverse events	Placebo	27	75
Total, other adverse events	JNJ-42165279 25 mg	26	74
Total, serious adverse events	Placebo	0	75
Total, serious adverse events	JNJ-42165279 25 mg	2	74

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33070154	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
JNJ-42165279 25 mg vs Placebo: deaths from any cause	Trial comparisons
JNJ-42165279 25 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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