Phase 2
N=160
An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress
Depressive Disorder · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02498392 ↗Enrolled (actual)
160
Serious AEs
1.3%
Results posted
Apr 2022
Primary outcome: Primary: Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 6 (eITT Population) — -6.1; -6.5 Units on a scale — p== 0.416
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JNJ-42165279 (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 6 (eITT Population) |
-6.1; -6.5 | = 0.416 |
| PRIMARY Double-blind Treatment Period: Change From Baseline in HDRS17 Total Score at Week 6 (fITT Population) |
-5.0; -5.2 | = 0.647 |
| SECONDARY Double-blind Treatment Period: Change From Baseline in Hamilton Anxiety Rating Subscale (HAM-A6) Score at Week 6 (eITT Population) |
-2.4; -2.9 | — |
| SECONDARY Double-blind Treatment Period: Change From Baseline in HAM-A6 Score at Week 6 (fITT Population) |
-2.1; -2.2 | — |
| SECONDARY Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Subscale (HAM-D6) Score at Week 6 (eITT Population) |
-3.1; -3.6 | — |
| SECONDARY Double-blind Treatment Period: Change From Baseline in HAM-D6 Score at Week 6 (fITT Population) |
-2.6; -2.8 | — |
| SECONDARY 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) |
-5.7; -6.8 | — |
| SECONDARY Double-blind Treatment Period: Change From Baseline in SIGH-A Total Score at Week 6 (fITT Population |
-5.0; -5.6 | — |
| SECONDARY Double-blind Treatment Period: Change From Baseline in the HDRS17 Anxiety/Somatization Factor Total Score at Week 6 (eITT Population) |
-2.1; -2.3 | — |
| SECONDARY Double-blind Treatment Period: Change From Baseline in the HDRS17 Anxiety/Somatization Factor Total Score at Week 6 (fITT Population) |
-1.7; -1.8 | — |
| SECONDARY 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) |
51.1; 55.3 | — |
| SECONDARY Double-blind Treatment Period: Percentage of Participants With >= 30 % Improvement on the HDRS17 Total Score at Week 6 (fITT Population) |
56.9; 52.2 | — |
| SECONDARY Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement in the HDRS17 Total Score at Week 6 (eITT Population) |
27.7; 21.3 | — |
| SECONDARY Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement in the HDRS17 Total Score at Week 6 (fITT Population) |
36.1; 27.5 | — |
| SECONDARY Double-blind Treatment Period: Percentage of Participants With >= 30% Improvement on SIGH-A Total Score at Week 6 (eITT Population) |
48.9; 51.1 | — |
| SECONDARY Double-blind Treatment Period: Percentage of Participants With >= 30% Improvement on SIGH-A Total Score at Week 6 (fITT Population) |
52.8; 52.2 | — |
| SECONDARY Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement on SIGH-A Total Score at Week 6 (eITT Population) |
29.8; 21.3 | — |
| SECONDARY Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement on SIGH-A Total Score at Week 6 (fITT Population) |
37.5; 24.6 | — |
| SECONDARY 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) |
14.9; 8.5 | — |
| SECONDARY Double-blind Treatment Period: Percentage of Participants With Remission as Assessed by HDRS17 Total Score <= 7 at Week 6 (fITT Population) |
33.3; 21.7 | — |
| SECONDARY 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) |
57.4; 55.3 | — |
| SECONDARY 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) |
65.3; 65.2 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of JNJ-42165279 |
217.7; 229.3 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Zero to Dosing Intervals (AUC[0-tau]) of JNJ-42165279 |
2159; 2432 | — |
| SECONDARY Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-42165279 |
NA | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT02498392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.