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An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress

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ClinicalTrials.gov Identifier: NCT02498392
Recruitment Status : Recruiting
First Posted : July 15, 2015
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety and tolerability of JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who have had inadequate response to treatment with a selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).

Condition or disease Intervention/treatment Phase
Depressive Disorder Anxiety Drug: JNJ-42165279 Other: Placebo Phase 2

Detailed Description:
This is a multicenter, double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled, randomized, parallel-group study in participants with Major Depressive Disorder (MDD) with Anxious Distress. Participants who had treatment initiated with a SSRI/SNRI allowed by the protocol will be evaluated at the investigation site. The site assessment will be reviewed and validated by an independent central rater. The review will include the clinical history of MDD, SSRI/SNRI treatment of adequate dose and duration for the current episode of depression, and current symptom severity on the Hamilton Depression Rating Scale (HDRS17). Enrolled participants will be maintained on SSRI/SNRI treatment throughout the study to determine whether additional treatment with JNJ-4216579 can reduce the symptoms of MDD with anxious distress.The study will consist of 3 phases: a Screening Phase of up to 4 weeks, an 11-week double-blind Treatment Phase, and a 3-week post-treatment (follow up) Phase. The double-blind treatment Phase of the trial will consist of 3 periods. The first period is a placebo lead-in of double-blind duration, after which participants will enter the treatment period when they will be randomly assigned to JNJ-42165279 or continuation on placebo for 6 weeks. Participants who successfully complete the treatment period prior to the end of Week 11, will be treated with placebo for the remaining time of the double-blind phase of the study, which will vary depending on the duration of the placebo lead-in for the specific participant. The total study duration for each participant will be approximately 18 weeks. Efficacy and safety of JNJ-42165279 will be evaluated. Participants' safety will be monitored throughout the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 143 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 Major Depressive Disorder With Anxious Distress
Actual Study Start Date : October 23, 2015
Estimated Primary Completion Date : February 18, 2019
Estimated Study Completion Date : March 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Placebo Comparator: Responders-Placebo
Participants who responded in the placebo lead-in period will be administered with Matching Placebo orally.
Other: Placebo
Matching Placebo will be administered orally.

Experimental: Responders-JNJ-42165279
Participants who responded in the placebo lead-in period will be administered with JNJ-42165279 orally at a dose of 25 milligrams (mg) tablets once daily for 6 weeks.
Drug: JNJ-42165279
JNJ-42165279 will be administered orally at a dose of 25 milligrams (mg) tablet once daily for 6 weeks.

Placebo Comparator: Non Responders-Placebo
Participants who did not respond in the placebo lead-in period will be administered with Matching Placebo orally.
Other: Placebo
Matching Placebo will be administered orally.

Experimental: Non Responders-JNJ-42165279
Participants who did not respond in the placebo lead-in period will be administered with JNJ-42165279 orally at a dose of 25 mg tablets once daily for 6 weeks.
Drug: JNJ-42165279
JNJ-42165279 will be administered orally at a dose of 25 milligrams (mg) tablet once daily for 6 weeks.




Primary Outcome Measures :
  1. Change from Baseline to Endpoint on the Hamilton Depression Rating Scale (HDRS17) Total Score [ Time Frame: Baseline and Week 6 ]
    The HDRS17 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. 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.


Secondary Outcome Measures :
  1. Change from Baseline to Endpoint on the Hamilton Anxiety Rating scale (HAM-A6) Score [ Time Frame: Baseline and Week 6 ]
    The HAM-A6 is a 6-item subscale derived from the original Hamilton Anxiety scale (HAM-A). The rating scale measures the severity of anxiety symptomatology. Higher scores represent more severe anxiety symptoms.

  2. Change from Baseline to Endpoint on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) Total Score [ Time Frame: Baseline and Week 6 ]
    The (HAM-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.

  3. Change from Baseline to Endpoint on the Hamilton Anxiety Rating scale (HAM-D6) Score [ Time Frame: Baseline and Week 6 ]
    The HAM-D6 is a 6-item subscale derived from the Hamilton Depression Rating Scale (HDRS17). The rating scale measures the severity of depressive symptomatology. Higher scores represent more severe depressive symptoms.

  4. Change from Baseline to Endpoint in the Hamilton Depression Rating Scale (HDRS17) Anxiety/Somatization Factor Total Score [ Time Frame: Baseline and Week 6 ]
    The anxiety/somatization factor total score derived from HDRS scale. It includes six items from the original 17-item version: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. The scale measures the severity of anxious depression. The higher the score, the more severe anxiety symptoms.

  5. Number of Participants with a Hamilton Depression Rating Scale (HDRS17) Anxiety/Somatization Factor Score Greater than or equal to 7 at Week 6 [ Time Frame: Week 6 ]
  6. Maximum Plasma Concentration (Cmax) of JNJ-42165279 [ Time Frame: Pre-dose and 2 to 4 hours post-dose on Day 14, 35, 63 and 77 ]
    The Cmax is the maximum observed plasma concentration of JNJ-42165279.

  7. Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-42165279 [ Time Frame: Pre-dose and 2 to 4 hours post-dose on Day 14, 35, 63 and 77 ]
    The Tmax is the time to reach the maximum observed plasma concentration of JNJ-42165279.

  8. Area Under the Plasma Concentration-time Curve From Time Zero to Dosing Interval [AUC(0-t)] [ Time Frame: Pre-dose and 2 to 4 hours post-dose on Day 14, 35, 63 and 77 ]
    AUC(0-t) is the area under the plasma concentration versus time curve from time 0 to Dosing Interval (t). AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.



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:

  • Participant must meet the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or 5 diagnostic criteria for major depressive disorder (MDD) with Anxious Distress
  • Participants with a diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or Panic Disorder may be included, if the investigator considers MDD with Anxious Distress to be the primary diagnosis (confirmed by an independent central rater at screening)
  • Participants must have been treated with an approved SSRI/SNRI antidepressants for at least 6 continuous weeks, validated by an independent central rater contracted by the sponsor
  • A 17-item Hamilton Depression Rating Scale (HDRS17) total score greater than or equal to (>=)18 and a HDRS17 anxiety/somatization factor score >=7 at screening, assessed by a site rater and reviewed by an independent central rater on Day 1
  • Participant must be willing and able to adhere to the prohibitions and restrictions
  • Participant Body mass index (BMI = weight/height2) must be between 18 and 35 kilogram per square meter (kg/m^2) inclusive

Exclusion Criteria:

  • Has other psychiatric condition, including, but not limited to, MDD with psychotic features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder, or schizophrenia
  • Has a length of current Major Depressive Episode (MDE) greater than (>) 6 months
  • Has more than 1 failed antidepressant treatment of adequate dose and duration in the current MDE, Not including the inadequate response to the current selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI) antidepressant
  • Has initiated psychotherapy specific for MDD (such as cognitive behavioral, behavioral, or interpersonal therapy) for the current episode of depression within 6 weeks prior to Screening
  • Has a current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year

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): NCT02498392


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 48 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02498392     History of Changes
Other Study ID Numbers: CR107733
2015-002007-29 ( EudraCT Number )
42165279MDD2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

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

Keywords provided by Janssen Research & Development, LLC:
Major Depressive Disorder
Depression
Anxiety symptoms
JNJ-42165279

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms