Completed
PHASE1
INTERVENTIONAL
NCT03374475
A Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Participants With Major Depressive Disorder
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study is to explore if the magnitude of treatment effect (JNJ-42847922; placebo) on symptoms of depression (as measured by Hamilton rating scale for depression-17 \[HDRS17\], Sleep item-adjusted HDRS17, Anxiety/somatization factor score and the 6-item subscale from HDRS17 \[HAM-D6\]) differs across different levels of hyper-arousal status (characterized by Sleep parameters, ruminative response scale \[RRS\], Sleep and Worry visual analogue scale \[VAS\], quantitative electro-encephalography \[qEEG\], heart rate variability \[HRV\] and others).
Interventions
Name:
JNJ-42847922 20mg
Type:
DRUG
Description:
Participants will swallow 20 mg (2\*10 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
Name:
JNJ-42847922 40mg
Type:
DRUG
Description:
Participants will swallow 40 mg (2\*20 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
Name:
Placebo
Type:
DRUG
Description:
All participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period.
Primary Outcomes
Measure:
Change From Baseline in Hamilton Rating Scale for Depression-17 (HDRS17) Total Score
TimeFrame:
Baseline up to Day 57
Description:
The HDRS17 is a Clinician-Administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a total score range of 0 to 52. It is the most widely used symptom severity measure for depression. Each of the 17 items is rated by the clinician on either a 3- point (0 to 2) or a 5-point scale (0 to 4). The point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Total score will be calculated by summing up the individual item score. The higher the score, the more severe the depression.
Measure:
Change From Baseline in Hamilton Rating Scale for Depression-17 (HDRS17) Sleep Item-Adjusted Total Score
TimeFrame:
Baseline up to Day 57
Description:
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. It is the most widely used symptom severity measure for depression. Each of the 17 items is rated by the clinician on either a 3- point (0 to 2) or a 5-point scale (0 to 4). The point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. HDRS17 Sleep Item-Adjusted is derived from the HDRS17 scale excluding the 3 sleep items (4, 5, and 6) from the total score.
Measure:
Change From Baseline in Hamilton Rating Scale for Depression-17 (HDRS17) Anxiety/Somatization Factor Score
TimeFrame:
Baseline up to Day 57
Description:
The HDRS17 anxiety/somatization factor derived from Cleary and Guy's factor analysis of the HDRS scale, includes six items from the original 17-item version: the items for psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. Anxious depression is often defined as Major Depressive Disorder (MDD) with high levels of anxiety symptoms, as reflected in an anxiety/ somatization factor score greater than or equal to (\>=) 7. The score ranges from 0 to 18, with higher scores indicating greater severity of symptoms.
Measure:
Change From Baseline in 6 Item Subscale From HDRS17 (HAM-D6) Score
TimeFrame:
Baseline up to Day 57
Description:
The 6-Item Hamilton Depression Scale (HAMD-6), derived by the sum of HAMD-17 items (the six items in the HAM-D6 are: depressed mood, guilt feelings, work and interests, psychomotor retardation, psychic anxiety, and general somatics \[tiredness and pains\]), 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.
Trial Information
NCT ID
NCT03374475
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Janssen Research & Development, LLC
Last Updated
December 15, 2025