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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Depressive Disorder, Major

Treatments: Other: Placebo; Drug: JNJ-42847922

Study type: Interventional

Funder types: Industry

Identifiers

NCT02067299

42847922EDI1002 (Other Identifier)

CR103409

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups

Cohort A

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: JNJ-42847922

Cohort B

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: JNJ-42847922

Cohort C

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: JNJ-42847922

Cohort D

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: JNJ-42847922