A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:1/30/2019
Start Date:August 16, 2017
End Date:January 19, 2019

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A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Adaptive Dose-Finding Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Subjects With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy

The purpose of this study is to assess the dose-response relationship of 2 doses of
JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis
results, compared to placebo as adjunctive therapy to an antidepressant drug in improving
depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an
inadequate response to current antidepressant therapy with a selective serotonin reuptake
inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the
safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an
antidepressant in participants with MDD.

The study will investigate the antidepressant effects of a range of doses of JNJ-42847922
(seltorexant) (versus placebo), as adjunctive treatment to antidepressant drugs for treatment
of MDD, and will assess the safety and tolerability of JNJ-42847922. The study will be
conducted in 3 phases: a screening phase (up to 4 weeks), a double-blind treatment phase (6
weeks), and a post-treatment follow-up phase (2 weeks). Efficacy, safety, pharmacokinetic,
and biomarker evaluations will be performed in the study at defined timepoints. The duration
of the study will be up to approximately 12 weeks (84 days).

Inclusion Criteria:

- Men or women of non-childbearing potential (WONCBP), aged 18 to 70 years (inclusive).
A WONCBP is defined as: a).Postmenopausal: A postmenopausal state is defined as no
menses for 12 months without an alternative medical cause. b). Permanently sterile:
Permanent sterilization methods include hysterectomy, bilateral salpingectomy,
bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. c). If
reproductive status is questionable, additional evaluation should be considered

- Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5)
diagnostic criteria for major depressive disorder (MDD), without psychotic features,
based upon clinical assessment and confirmed by the Structured Clinical Interview for
DSM-5 Axis I Disorders- Clinical Trials Version (SCID-CT). In addition their major
depressive episode must be deemed "valid" using the SCID Screening Questionnaire (SSQ)
interview administered by remote, independent raters. The length of the current
depressive episode must be less than or equal to (<=) 18 months

- Have had an inadequate response to at least 1 but no more than 3 antidepressants,
administered at an adequate dose and duration in the current episode of depression, as
measured by the Massachusetts General Hospital-Antidepressant Treatment Response
Questionnaire (MGH-ATRQ). An inadequate response is defined as less than (<)50 percent
(%) reduction in depressive symptom severity, as assessed by the MGH-ATRQ. An adequate
trial is defined as an antidepressant treatment for at least 4 weeks at or above the
minimum therapeutic dose specified in the MGH-ATRQ, for any particular antidepressant.
The inadequate response must include the participant's current antidepressant
treatment

- Participants receiving monotherapy treatment for depressive symptoms with one of the
following selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake
inhibitor (SSRI/SNRI) antidepressants, in any formulation: citalopram, duloxetine,
escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine,
sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose
(at or above the minimum therapeutic dose level) for at least 4 weeks, and for no
greater than 12 months, at screening. Modification of an effective preexisting therapy
should not be made for the explicit purpose of entering a subject into the study

- Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or
equal to (>=)25 (performed by independent, centralized remote raters) at screening and
must not demonstrate a clinically significant improvement (that is, an improvement of
greater than [>]20% on their MADRS total score) from the screening to baseline visit

- Must be otherwise healthy on the basis of physical examination, medical history, vital
signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at
screening. If the results of the clinical laboratory tests are outside the normal
reference ranges, the participant could be included only if the investigator judges
the abnormalities or deviations from normal to be not clinically significant or to be
appropriate and reasonable for the population under study. This determination must be
recorded in the participant's source documents and initialed by the investigator

Exclusion Criteria:

- Has a history of, or current signs and symptoms of, severe renal insufficiency
(creatinine clearance <30 milliliter per minute [mL/min]); moderate to severe hepatic
insufficiency (Child-Pugh Score 7-9), significant or unstable cardiovascular,
respiratory, gastrointestinal, neurologic (including narcolepsy), hematologic,
rheumatologic, immunologic or endocrine disorders (including uncontrolled hypo- or
hyperthyroidism or diabetes, or insulin-dependent diabetes mellitus). Participants
with non-insulin dependent diabetes mellitus who are well-controlled (hemoglobin A1C
[HbA1C] <=7.5% and fasting glucose <126 milligram per deciliter [mg/dL] at screening)
could be eligible to participate if otherwise medically healthy, and if on a stable
regimen of glucose-lowering medications for at least 2 months prior to screening

- Has signs and symptoms of Cushing's Disease, Addison's Disease, primary amenorrhea, or
other evidence of significant medical disorders of the hypothalamic-pituitary-adrenal
(HPA) axis

- Has a history of lack of response to 3 or more adequate antidepressant treatments, as
indicated by no or minimal (<= 25% improvement in symptoms) when treated with an
antidepressant of adequate dose (per MGH-ATRQ) and duration (at least 4 weeks)

- Has history or current diagnosis of a psychotic disorder, bipolar disorder, mental
retardation, autism spectrum disorder, or borderline personality disorder, somatoform
disorders, chronic fatigue syndrome or fibromyalgia

- Has any significant primary sleep disorder, including but not limited to obstructive
sleep apnea, restless leg syndrome, or parasomnias
We found this trial at
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1330 Lincoln Avenue
SAN RAFAEL, California 94901
(949) 683-1123
We are psychiatry clinic and a research facility based in San Rafael, California
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Atlanta, Georgia
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Chicago, Illinois 60634
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Chicago, Illinois 60640
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Chino, California 91710
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Everett, Washington 98201
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Gainesville, Florida 32607
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Jacksonville, Florida 32216
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Joliet, Illinois 60435
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Lauderhill, Florida 33319
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Lemon Grove, California 91945
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Media, Pennsylvania 19063
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Miami, Florida 33243
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Miami Springs, Florida 33166
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New York, New York 10019
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Panorama City, California 91402
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Staten Island, New York 10312
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The Woodlands, Texas 77381
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Wildomar, California 92595
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Winston-Salem, North Carolina 27157
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Winston-Salem, North Carolina 27103
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