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

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ClinicalTrials.gov Identifier: NCT02432703
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment Phase
Phobic Disorders Drug: JNJ-42165279 Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : June 15, 2015
Actual Primary Completion Date : August 9, 2018
Actual Study Completion Date : August 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: JNJ-42165279
Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.
Drug: 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.
Drug: Placebo
Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.




Primary Outcome Measures :
  1. Change From Baseline in the Liebowitz Social Anxiety Scale (LSAS) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    The Liebowitz Social Anxiety Scale (LSAS) is a 24-item measure designed to assess both fear and avoidance of social and performance situations. The total score ranges from 0 to 144; where higher score indicates worsening.


Secondary Outcome Measures :
  1. Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Fear/Anxiety and Avoidance Subscales at Week 12 [ Time Frame: Baseline and Week 12 ]
    The 24-items on LSAS scale assess both fear and avoidance of social and performance situations. Each item is rated from 0-3 for both fear and avoidance with the total subscale score ranging from 0 to 72 each; where higher score indicates worsening.

  2. Number of Participants who are Responders and Remitters on Liebowitz Social Anxiety Scale (LSAS) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Responders are participants with greater than or equal (>=) 50 percent (%) improvement from baseline and remitters are participants with >= 30% improvement from baseline on LSAS total score.

  3. Percentage of Participants who are Responders and Remitters on Liebowitz Social Anxiety Scale (LSAS) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Percentage of Participants who would be responders and remitters on Liebowitz Social Anxiety Scale (LSAS) Total Score will be observed.

  4. Change from Baseline in Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom. The total score ranges from 0 to 56, where higher score indicates worsening.

  5. Change from Baseline in Hamilton Anxiety Rating scale (HAM-A6) Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Hamilton Anxiety Rating scale (HAM-A6) is a 6-item subscale derived from the original Hamilton Anxiety scale (HAM-A). It comprises 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, with a total score range of 0 to 24. The rating scale measures the severity of anxiety symptomatology. Higher scores represent more severe anxiety symptoms.

  6. Change from Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Hamilton Depression Rating Scale (HDRS17) is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a total score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression.

  7. Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Hamilton Depression Rating Scale (HDRS17) used to assess the anxiety/somatization factor. The total score ranges from 0 to 18. The higher the score, the more severe the depression.

  8. Change From Baseline in 6-Item Hamilton Depression Scale (HAM-D6) Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    The 6-Item Hamilton Depression Scale (HAMD-6), derived by the sum of HAMD-17 items 1, 2, 7, 8, 10 and 13, evaluates "core" symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe). The higher the score, the more severe the depression.

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

  10. Number of Participants who are Responders on SIGH-A Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Responders are participants with >= 50% improvement from baseline on SIGH-A total score as assessed at the 12-week endpoint.

  11. Percentage of Participants who are Responders on SIGH-A Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    Percentage of participants who are responders will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a primary DSM-5 diagnosis of Social anxiety disorder (SAD) except those with performance only as a specifier. Participants with a diagnosis of comorbid Generalized Anxiety Disorder (GAD) or Major Depressive Disorder (MDD) may be included if the Investigator considers SAD to be the predominant diagnosis. Participants with current or lifetime history of Attention deficit hyperactivity disorder (ADHD) and specific phobia may be included as well
  • Must have a Liebowitz Social Anxiety Scale score greater than or equal (>=) 70 at Screening and Baseline
  • Participants with a current episode of MDD must have a HDRS17 total score less than or equal to (<=) 18
  • Must have a body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m^2), inclusive, at screening
  • Female participants must be either postmenopausal or surgically sterile

Exclusion Criteria:

  • Participants who have performance only SAD are excluded. Participants with other current significant psychiatric condition(s) (Axis 1 under DSM-IV), including, but not limited to, MDD with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (e.g., bulimia, anorexia nervosa), autism spectrum disorders, post-traumatic stress disorder (PTSD) or schizophrenia are excluded. Participants with a diagnosis of comorbid GAD or MDD may be included
  • Participants is currently receiving specific psychotherapy for SAD
  • Has a history of more than two unsuccessful adequate pharmacological treatment trials for SAD, defined as lack of response to at least 10 weeks of treatment at adequate doses (e.g., paroxetine >= 40 milligram per day (mg/day) or its equivalent; or clonazepam >= 2.5 mg/day or its equivalent)
  • Concurrent use of psychotropic medications
  • has a history of or current thyroid disease, thyroid dysfunction and is currently untreated for it

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432703


Locations
United States, California
La Jolla, California, United States
United States, Connecticut
Hartford, Connecticut, United States
United States, Florida
Orlando, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
Natick, Massachusetts, United States
United States, New York
New York, New York, United States
Rochester, New York, United States
Staten Island, New York, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
Reading, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Australia
Adelaide, Australia
Frankston, Australia
Melbourne, Australia
Perth, Australia
Canada, Alberta
Edmonton, Alberta, Canada
Canada, Ontario
Hamilton, Ontario, Canada
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02432703     History of Changes
Other Study ID Numbers: CR106641
42165279SAX2001 ( Other Identifier: Janssen Research & Development, LLC )
2014-004258-32 ( EudraCT Number )
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Social Anxiety Disorder
JNJ-42165279

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Phobia, Social
Phobic Disorders
Pathologic Processes
Mental Disorders