NCT02067299

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2014

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

January 22, 2014

Last Update Submit

February 3, 2016

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder, MajorMajor Depressive DisorderInsomniaJNJ-42847922Placebo

Outcome Measures

Primary Outcomes (1)

  • Latency to Persistent Sleep (LPS) on Day 1

    LPS is with lights off, appearance of first epoch of Stage 1 (light sleep), Stage 2 (light sleep), Stage 3 (deep sleep), and Stage 4 (rapid eye movement sleep) sleep followed by at least 20 consecutive epochs without any Stage 0 sleep (awake but sleepy). LPS will be accessed on Day 1 of each treatment period (Periods 1, 2, 3, and 4).

    Day 1

Secondary Outcomes (17)

  • Number of participants with adverse events

    Up to Week 10

  • Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922

    Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-42847922

    Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Time 12 (AUC[12])

    Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)

  • Total amount of JNJ-42847922 excreted in urine (Ae12)

    Predose and postdose Day 1

  • +12 more secondary outcomes

Study Arms (4)

Cohort A

EXPERIMENTAL

5 participants will be included in this cohort. Participants will receive the study medications in the sequence of placebo (Period 1), JNJ-42847922 10 mg (Period 2), JNJ-42847922 20 mg (Period 3), and JNJ-42847922 40 mg (Period 4). Each treatment period and each subsequent treatment period will be separated by 1 week.

Drug: JNJ-42847922Other: Placebo

Cohort B

EXPERIMENTAL

5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 10 mg (Period 1), JNJ-42847922 40 mg (Period 2), placebo (Period 3), and JNJ-42847922 20 mg (Period 4). Each subsequent treatment period will be separated by 1 week.

Drug: JNJ-42847922Other: Placebo

Cohort C

EXPERIMENTAL

5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 20 mg (Period 1), placebo (Period 2), JNJ-42847922 40 mg (Period 3), and JNJ-42847922 10 mg (Period 4). Each subsequent treatment period will be separated by 1 week.

Drug: JNJ-42847922Other: Placebo

Cohort D

EXPERIMENTAL

5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 40 mg (Period 1), JNJ-42847922 20 mg (Period 2), JNJ-42847922 10 mg (Period 3), and placebo (Period 4). Each subsequent treatment period will be separated by 1 week.

Drug: JNJ-42847922Other: Placebo

Interventions

JNJ-42847922DRUG

Participants will receive suspension of JNJ-42847922 (10 mg, 20 mg, and 40 mg) orally on Day 1 of the appropriate treatment periods.

Cohort ACohort BCohort CCohort D
PlaceboOTHER

Participants will receive placebo orally on Day 1 of the appropriate treatment periods.

Cohort ACohort BCohort CCohort D

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Leiden, Netherlands

Location

MeSH Terms

Conditions

Depressive Disorder, MajorSleep Initiation and Maintenance Disorders

Interventions

seltorexant

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Janssen Research & Development, L.L. C. Clinical Trial

    Janssen Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

February 20, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

NL(1)DE(1)