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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02067299
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: JNJ-42847922 Other: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A
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-42847922
Participants will receive suspension of JNJ-42847922 (10 mg, 20 mg, and 40 mg) orally on Day 1 of the appropriate treatment periods.

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

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

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

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

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

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

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




Primary Outcome Measures :
  1. Latency to Persistent Sleep (LPS) on Day 1 [ Time Frame: 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).


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Up to Week 10 ]
  2. Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922 [ Time Frame: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours) ]
    Cmax is defined as maximum observed analyte concentration. This will be measured on Day 1 of each treatment period (Periods 1, 2, 3, and 4).

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-42847922 [ Time Frame: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours) ]
    Tmax is defined as actual sampling time to reach maximum observed analyte concentration. This be measured on Day 1 of each treatment period (Periods 1, 2, 3, and 4).

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Time 12 (AUC[12]) [ Time Frame: 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 is area under the plasma concentration-time curve from 0 to 12 hours post dosing. This will be measured on Day 1 of each treatment period (Periods 1, 2, 3, and 4).

  5. Total amount of JNJ-42847922 excreted in urine (Ae12) [ Time Frame: Predose and postdose Day 1 ]
    Total amount of JNJ-42847922 excreted in urine is expressed as a percentage of dose administered. This will be measured overnight after the administration of the study medication on Day 1 of each treatment period (Periods 1, 2, 3, and 4).

  6. Renal clearance (CLR) [ Time Frame: Predose and postdose Day 1 ]
    CLR will be measured overnight after the administration of the study medication on Day 1 of each treatment period (Periods 1, 2, 3, and 4).

  7. Number of participants with suicidal ideation or behavior measured using Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Screening (Day -28 to Day -2), Day 1, and Day 2 ]
    C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).

  8. Total sleep time in participants [ Time Frame: Screening (Day -28 to Day -2), Day 1, and Day 2 ]
    This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).

  9. Sleep efficiency in participants [ Time Frame: Screening (Day -28 to Day -2), Day 1, and Day 2 ]
    This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).

  10. Next-day residual effect of JNJ-42847922 measured using visual analogue scale (VAS) for sleepiness [ Time Frame: Screening (Day -28 to Day -2), Day 1, and Day 2 ]
    VAS scale is ued to measure subjective characteristics or attitudes that cannot be measured directly for sleepiness. VAS will assess whether the participants were feeling sleepy during the first hour after wake-up by using a 10 cm line, having sleepy/tired and awake at either end. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).

  11. Next-day residual effect of JNJ-42847922 measured using the Bond and Lader visual analogue scale (VAS) to rate subjective feelings [ Time Frame: Screening (Day -28 to Day -2), Day 1, and Day 2 ]
    The Bond-Lader Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end of a 10 cm line. Participants were asked to rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item was scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria were then calculated from the combined scores of selected items. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).

  12. Next-day residual effect of JNJ-42847922 on body movements measured using a pot string meter and a stabilometric platform [ Time Frame: Screening (Day -28 to Day -2), Day 1, and Day 2 ]
    A pot string meter includes a string attached the waist of the participant and all body movements over a period of time are integrated and expressed as mm sway. In a stabilometric platform, the participant will be made to sleep on a firm surface for about 51.2 seconds each with first eyes open and then eyes closed. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).

  13. Next-day residual effect of JNJ-42847922 on saccadic eye movements [ Time Frame: Screening (Day -28 to Day -2), Day 1, and Day 2 ]
    Saccadic eye movements will be assessed using a computer-based system connected to electrodes placed lateral of the eyes or using infra-red technology. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).

  14. Number of participants with depressive symptoms measured using Quick Inventory of Depressive Symptomatology - Self Report 14-item (QIDS-SR14) [ Time Frame: Screening (Day -28 to Day -2), Day 1, and Day 2 ]
    The QIDS-SR14, s a version of the QIDS-SR16 with a shorter, 24-hour recall period that has been developed for this trial. The total score ranges from 0 to 27. Using a scale of severity of depression of none, mild, moderate, severe, and very severe, corresponding QIDS-SR16 total scores are none 1-5, mild 6-10, moderate 11-15, severe 16-20 and very severe 21-27. Higher scores indicate worsening. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).

  15. Concentration of cortisol in saliva [ Time Frame: Predose Day 1 (30 minutes and 90 minutes) and postdose Day 2 (at wake-up and 30 minutes after wake-up) ]
    This will be measured on Day 1 of each treatment period (Periods 1, 2, 3, and 4).

  16. Time spent awake by the participants [ Time Frame: Screening (Day -28 to Day -2) and Day 1 ]
    This will be assessed on Day 1 of each treatment period (Periods 1, 2, 3, and 4).

  17. Total time spent deep sleep by the participants [ Time Frame: Screening (Day -28 to Day -2) and Day 1 ]
    This will be assessed on Day 1 of each treatment period (Periods 1, 2, 3, and 4).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067299


Locations
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Germany
Berlin, Germany
Netherlands
Leiden, Netherlands
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, L.L. C. Clinical Trial Janssen Research & Development, L.L.C.
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02067299    
Other Study ID Numbers: CR103409
42847922EDI1002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Keywords provided by Janssen Research & Development, LLC:
Depressive Disorder, Major
Major Depressive Disorder
Insomnia
JNJ-42847922
Placebo
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases