Clinical trial NCT02498392: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Anxiety
Keywords: Major Depressive Disorder
Depression
Anxiety symptoms
JNJ-42165279
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-07-15
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 6 (eITT Population)
timeFrame: Baseline and Week 6
measure: Double-blind Treatment Period: Change From Baseline in HDRS17 Total Score at Week 6 (fITT Population)
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Double-blind Treatment Period: Change From Baseline in Hamilton Anxiety Rating Subscale (HAM-A6) Score at Week 6 (eITT Population)
timeFrame: Baseline and Week 6
measure: Double-blind Treatment Period: Change From Baseline in HAM-A6 Score at Week 6 (fITT Population)
timeFrame: Baseline and Week 6
measure: Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Subscale (HAM-D6) Score at Week 6 (eITT Population)
timeFrame: Baseline and Week 6
measure: Double-blind Treatment Period: Change From Baseline in HAM-D6 Score at Week 6 (fITT Population)
timeFrame: Baseline and Week 6
measure: Double-blind Treatment Period: Change From Baseline in Structured Interview Guide of the Hamilton Anxiety Scale (SIGH-A) Total Score at Week 6 (eITT Population)
timeFrame: Baseline and Week 6
measure: Double-blind Treatment Period: Change From Baseline in SIGH-A Total Score at Week 6 (fITT Population
timeFrame: Baseline and Week 6
measure: Double-blind Treatment Period: Change From Baseline in the HDRS17 Anxiety/Somatization Factor Total Score at Week 6 (eITT Population)
timeFrame: Baseline and Week 6
measure: Double-blind Treatment Period: Change From Baseline in the HDRS17 Anxiety/Somatization Factor Total Score at Week 6 (fITT Population)
timeFrame: Baseline and Week 6
measure: Double-blind Treatment Period: Percentage of Participants With Greater Than or Equal to (>=) 30 Percent (%) Improvement on the HDRS17 Total Score at Week 6 (eITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With >= 30 % Improvement on the HDRS17 Total Score at Week 6 (fITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement in the HDRS17 Total Score at Week 6 (eITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement in the HDRS17 Total Score at Week 6 (fITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With >= 30% Improvement on SIGH-A Total Score at Week 6 (eITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With >= 30% Improvement on SIGH-A Total Score at Week 6 (fITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement on SIGH-A Total Score at Week 6 (eITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement on SIGH-A Total Score at Week 6 (fITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With Remission as Assessed by HDRS17 Total Score Less Than or Equal to (<=) 7 at Week 6 (eITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With Remission as Assessed by HDRS17 Total Score <= 7 at Week 6 (fITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With a Clinical Global Impression Improvement (CGI-I) Score of Very Much Improved or Much Improved at Week 6 (eITT Population)
timeFrame: Week 6
measure: Double-blind Treatment Period: Percentage of Participants With a Clinical Global Impression Improvement (CGI-I) Score of Very Much Improved or Much Improved at Week 6 (fITT Population)
timeFrame: Week 6
measure: Maximum Plasma Concentration (Cmax) of JNJ-42165279
timeFrame: Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77
measure: Area Under the Plasma Concentration-time Curve From Zero to Dosing Intervals (AUC[0-tau]) of JNJ-42165279
timeFrame: Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77
measure: Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-42165279
timeFrame: Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77
Other outcomes:
Locations:
city: Costa Mesa
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Natick
country: United States
state: Massachusetts
city: Cedarhurst
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Allentown
country: United States
state: Pennsylvania
city: Salt Lake City
country: United States
state: Utah
city: Chisinau
country: Moldova, Republic of
city: Ekaterinburg
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Sant Boi de Llobregat
country: Spain
city: Zamora
country: Spain
city: Glevakha
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Smila
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Barnsley
country: United Kingdom
city: Blackpool
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Manchester
country: United Kingdom
city: South Staffordshire
country: United Kingdom
city: Stourton
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: