Clinical trial NCT02067299: A Study to Investigate the Effect of JNJ-42847922 on Polysomnography Measures in Patients With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants
Official title: A Single Dose, 4-way Crossover, Placebo-controlled, Randomized Study to Investigate the Effect of JNJ-42847922 on Polysomnography (PSG) Measures in Subjects With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder, Major
Keywords: Depressive Disorder, Major
Major Depressive Disorder
Insomnia
JNJ-42847922
Placebo
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to persistent sleep) in participants with major depressive disorder who are stably treated with selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who suffer from insomnia (inability to fall asleep).

Detailed description: This is a double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (placebo is compared with the study medication to test whether the study medication has a real effect in clinical study), randomized (the study medication is assigned by chance) 4-way crossover (method used to switch participants to 4 different arms in a clinical study), and a single dose study. This study will consist of a screening phase (between 28 to 2 days prior to the study medication), a treatment phase of 4 double blind study periods (2 days), and a follow-up phase (within 7 to 14 days after last dose of the study medication). Approximately 20 participants with major depressive disorder will participate in this study. Participants will be randomly assigned to 1 of 4 cohorts (groups) (Cohorts A, B, C, and D) to receive JNJ-42847922 (10 mg, 20 mg, and 40 mg) and placebo. Each cohort consists of 4 treatment periods (Periods 1, 2, 3, and 4). Safety will be evaluated by the assessment vital signs, 12-lead electrocardiogram, clinical laboratory testing, physical examination, and neurological examination. The total duration of study participation for a participant will be approximately 9 to 10 weeks.

Eligibility criteria: Inclusion Criteria:

* Participants with a current/recurrent or past episode of Major Depressive Disorder (MDD) as established per mini international neuropsychiatric interview at screening or otherwise specified by the treating physician
* Stably treated with selective serotonin re-uptake inhibitor / serotonin-norepinephrine reuptake inhibitor monotherapy, with no change in dose in the last 30 days before screening
* Insomnia per polysomnography (a diagnostic test to measure and record physiologic variables like latency to persistent sleep, total sleep time, sleep efficiency, time spent awake, and total time spent in deep sleep, during sleep)
* Participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening
* Female participants should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years)

Exclusion Criteria:

* Has a current diagnosis of a psychotic disorder, MDD with psychosis, bipolar disorder, mental retardation, or cluster B personality disorder (eg, borderline personality disorders, antisocial personality disorder)
* Has been diagnosed with sleep-related breathing disorder
* Has suicidal ideation with some intent to act, or has homicidal ideation/intent, per Principal Investigator's clinical judgment
* Abnormal day/night rhythm, eg, nightshift worker, or normal bed time past midnight
* Has uncontrolled hypertension at screening and Day 1 prior to randomization; or any past history of hypertensive crisis

Primary outcomes:
measure: Latency to Persistent Sleep (LPS) on Day 1
timeFrame: Day 1
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to Week 10
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922
timeFrame: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-42847922
timeFrame: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 12 (AUC[12])
timeFrame: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)
measure: Total amount of JNJ-42847922 excreted in urine (Ae12)
timeFrame: Predose and postdose Day 1
measure: Renal clearance (CLR)
timeFrame: Predose and postdose Day 1
measure: Number of participants with suicidal ideation or behavior measured using Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Screening (Day -28 to Day -2), Day 1, and Day 2
measure: Total sleep time in participants
timeFrame: Screening (Day -28 to Day -2), Day 1, and Day 2
measure: Sleep efficiency in participants
timeFrame: Screening (Day -28 to Day -2), Day 1, and Day 2
measure: Next-day residual effect of JNJ-42847922 measured using visual analogue scale (VAS) for sleepiness
timeFrame: Screening (Day -28 to Day -2), Day 1, and Day 2
measure: Next-day residual effect of JNJ-42847922 measured using the Bond and Lader visual analogue scale (VAS) to rate subjective feelings
timeFrame: Screening (Day -28 to Day -2), Day 1, and Day 2
measure: Next-day residual effect of JNJ-42847922 on body movements measured using a pot string meter and a stabilometric platform
timeFrame: Screening (Day -28 to Day -2), Day 1, and Day 2
measure: Next-day residual effect of JNJ-42847922 on saccadic eye movements
timeFrame: Screening (Day -28 to Day -2), Day 1, and Day 2
measure: Number of participants with depressive symptoms measured using Quick Inventory of Depressive Symptomatology - Self Report 14-item (QIDS-SR14)
timeFrame: Screening (Day -28 to Day -2), Day 1, and Day 2
measure: Concentration of cortisol in saliva
timeFrame: Predose Day 1 (30 minutes and 90 minutes) and postdose Day 2 (at wake-up and 30 minutes after wake-up)
measure: Time spent awake by the participants
timeFrame: Screening (Day -28 to Day -2) and Day 1
measure: Total time spent deep sleep by the participants
timeFrame: Screening (Day -28 to Day -2) and Day 1
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Leiden
country: Netherlands
Study officials:
affiliation: Janssen Research & Development, L.L.C.
name: Janssen Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: