Depression MDD
Conditions
Interventions
JNJ-42847922 is a potent and selective antagonist of the human orexin-2
receptor (OX2R) that is being developed for the treatment of major depressive
disorder (MDD) and the treatment of insomnia dis
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 55 years of age (inclusive). 2. Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive 3. Meets DSM (edition IV or 5) diagnostic criteria for MDD (ICD-code F32.x and F33.x), without psychotic features, and confirmed by the MINI. The length of the current depressive episode must be 25 at screening and must not demonstrate a clinically significant change (i.e., an improvement of >20% on their MADRS total score) from the screening to baseline visit, i.e., subjects must have a MADRS total score of at least 20 at the baseline visit. 5. Not currently receive antidepressant drug therapy for >= 2 weeks before screening.
Exclusion criteria
Exclusion criteria: 1. Current or past clinically significant disease of the renal, hepatic, musculoskeletal, gastrointestinal, cardiovascular systems, immunological, endocrine, metabolic, or neurological disease. 2. Signs or symptoms of Cushing*s Disease, Addison*s Disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis. 3. Primary DSM (4th or 5th edition) diagnosis of general anxiety disorder (GAD), panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD). 4. Current or recent history of clinically significant suicidal ideation within the past 6 months. 5. History of drug or alcohol abuse or dependence according to DSM-IV or 5 criteria, except nicotine or caffeine, within 6 months before screening. 6. Prior electroconvulsive therapy (ECT), vagal nerve stimulation (VNS), or a deep brain stimulation (DBS) device. 7. Narcolepsy, severe obstructive sleep apnea/hypopnea, central sleep apnea, sleep-related, hypoventilation, circadian rhythm sleep-wake disorders, diagnosed with severe restless legs syndrome, substance/medication-induced sleep disorder or parasomnias (NREM sleep arousal disorders, nightmare disorder, REM sleep behavior disorder).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms: the structured interview guide for the Hamilton Depression Scale (SIGH-D) will be completed at baseline and during the visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mood Symptoms: • the MADRS • the QIDS-SR16, B&L VAS and the POMS Cognitive function: • A cognitive test battery that includes tests to evaluate attention, immediate and delayed verbal and visual memory, working memory, and executive function. Sleep quality: • the time to sleep onset, total sleep time (TST), time awake during the night and time of awakening will be recorded in a sleep diary. • For polysomnography (PSG) measurements subjects will be instructed to go to bed between 10:00 pm and 12:00 am (midnight) and remain in bed for 8 hours. TST, wake after sleep onset, latency to persistent sleep, time spent awake, time spent in deep sleep, and sleep efficiency will be registered. Rumination: • the Ruminative Response Scale (RRS), a 22 item self-report measure of rumination, the Sleep and worry VAS which asks the subjects in the morning after wake up whether they could not sleep due to worrying and ongoing thoughts. Hyperarousal: Heart Rate Variability (HRV) will be derived from Holter recordings overnight and will be evaluated for arousal. Quantitative EEG (qEEG) will be recorded in a quiet environment with the eyes open for 2 minute and the eyes closed for 2 minutes. Pharmacokinetic endpoints Venous blood samples of 3 mL will be collected for determination of JNJ-42847922 plasma concentrations and metabolites. Tolerability / safety endpoints Adverse events will be reported from screening until follow-up. Because of the mechanism of action, investigators should pay special attention to parasomnias and episodes of cataplexy. Safety parameters like blood pressure, pulse/heart rate measurements, temperature physical examination and ECG will be performed for safety monitoring. An interview (the C-SSRS) to assess the risk of suicidal ideation and behavior will be conducted. | — |
Countries
Netherlands
Outcome results
None listed