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

NCT02498392 | Completed Phase 2 Results

• 3 other identifiers: CR1077332015-002007-2942165279MDD2001
• Study Type: interventional
• Target: 161
• Locations: 6 countries
• Sites: 32

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).

Conditions

Depressive Disorder; Anxiety

Keywords

Major Depressive Disorder; Depression; Anxiety symptoms; JNJ-42165279

Outcome Measures

Primary Outcomes (2)

• Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 6 (eITT Population)

  HDRS17 is clinician-administered rating scale designed to assess severity of symptoms in participants diagnosed with depression. Each of 17 items is rated by clinician on either 3-point (0-2) or 5-point (0-4) scale with 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 scores of all 17 items. For each item as well as total score, higher score represents more severe condition.

  Baseline and Week 6

• Double-blind Treatment Period: Change From Baseline in HDRS17 Total Score at Week 6 (fITT Population)

  HDRS17 is a clinician-administered rating scale designed to assess severity of symptoms in participants diagnosed with depression. Each of the 17 items is rated by clinician on either a 3-point (0 to 2) or a 5-point (0 to 4) scale which used a rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. HDRS17 total score is calculated as sum of 17 item scores and ranges from 0 to 52. For each item as well as the total score, higher scores indicate greater severity of depression.

  Baseline and Week 6

Secondary Outcomes (23)

• Double-blind Treatment Period: Change From Baseline in Hamilton Anxiety Rating Subscale (HAM-A6) Score at Week 6 (eITT Population)

  Baseline and Week 6

• Double-blind Treatment Period: Change From Baseline in HAM-A6 Score at Week 6 (fITT Population)

  Baseline and Week 6

• Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Subscale (HAM-D6) Score at Week 6 (eITT Population)

  Baseline and Week 6

• Double-blind Treatment Period: Change From Baseline in HAM-D6 Score at Week 6 (fITT Population)

  Baseline and Week 6

• 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)

  Baseline and Week 6

Study Arms (4)

Responders-Placebo

PLACEBO COMPARATOR

Participants who responded in the placebo lead-in period will be administered with Matching Placebo orally.

Other: Placebo

Responders-JNJ-42165279

EXPERIMENTAL

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

Non Responders-Placebo

PLACEBO COMPARATOR

Participants who did not respond in the placebo lead-in period will be administered with Matching Placebo orally.

Other: Placebo

Non Responders-JNJ-42165279

EXPERIMENTAL

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

Interventions

JNJ-42165279 DRUG

JNJ-42165279 will be administered orally at a dose of 25 milligrams (mg) tablet once daily for 6 weeks.

Non Responders-JNJ-42165279; Responders-JNJ-42165279

Placebo OTHER

Matching Placebo will be administered orally.

Non Responders-Placebo; Responders-Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (32)

Unknown Facility

Costa Mesa, California, United States

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Oceanside, California, United States

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Miami, Florida, United States

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Natick, Massachusetts, United States

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Cedarhurst, New York, United States

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Raleigh, North Carolina, United States

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Allentown, Pennsylvania, United States

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Salt Lake City, Utah, United States

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Chisinau, Moldova

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Orenburg, Russia

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Saint Petersburg, Russia

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Saratov, Russia

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Tomsk, Russia

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Yekaterinburg, Russia

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Alicante, Spain

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Barcelona, Spain

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Bilbao, Spain

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Sant Boi de Llobregat, Spain

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Zamora, Spain

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Hlevakha, Ukraine

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Kharkiv, Ukraine

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Kherson, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Smila, Ukraine

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Uzhhorod, Ukraine

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Barnsley, United Kingdom

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Blackpool, United Kingdom

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Liverpool, United Kingdom

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Manchester, United Kingdom

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South Staffordshire, United Kingdom

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Stourton, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major; Depression

Interventions

JNJ-42165279

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

The relationship of plasma anandamide and trough drug concentrations observed suggest that few participants had substantial recovery of fatty acid amide hydrolase activity between doses. Higher doses or exposures could have resulted in greater effects.

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 15, 2015
• Study Start: October 7, 2015
• Primary Completion: February 4, 2019
• Study Completion: February 4, 2019
• Last Updated: April 29, 2025
• Results First Posted: April 7, 2022

Record last verified: 2025-04

Locations

RU (5); UA (7); MO (1); US (8); ES (5); GB (6)