Clinical trial NCT02476058: A Safety, Efficacy and Biomarker Study of JNJ-42847922 in Participants With Major Depressive Disorder
Official title: An Exploratory Multicenter, Double-Blind, Diphenhydramine- and Placebo-Controlled Safety, Efficacy and Biomarker Study With JNJ-42847922 in Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
JNJ-42847922
Diphenhydramine
Placebo
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2015-06-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of JNJ-42847922 in participants with Major Depressive Disorder (MDD).

Detailed description: This will be a multi-center (when more than one hospital works on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving) and placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. This study will consist of an eligibility screening examination (between 28 days and 1 day prior to the first dose administration), a parallel group treatment phase of 10 days or 4 weeks, and a follow-up period of 2 weeks including 2 follow-up visits. The duration of study will be 12 months. Participants will be randomly assigned to receive either JNJ-42847922, Diphenhydramine or Placebo. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Before randomization, a woman must be either: 1) Not of childbearing potential: postmenopausal; permanently sterilized; or otherwise be incapable of pregnancy. 2) Of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS) in combination with barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence. Women must agree to continue using these methods of contraception throughout the study and for at least 3 months after receiving the last dose of study medication
* Participant Body mass index (BMI) must be between 18 and 30 kilogram per square meter (kg/m2) inclusive
* Participant must meet the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or 5 diagnostic criteria for major depressive disorder (MDD) without psychotic features, and confirmed by the Mini International Neuropsychiatric Interview (MINI) 6.0; Participant must have an Inventory of Depressive Symptomatology- Clinician rated-30 (IDS-C30) total score greater than or equal to (\>=) 30; Participant is either currently antidepressant naive or currently being treated with a maximum of two concurrent antidepressants. If the subject is currently treated with antidepressants, they have to be given at an optimal dose and for at least 4 weeks, but not longer than 24 weeks with a suboptimal response
* A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug
* Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

* Women who is pregnant or breast feeding
* Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's study responsible physician, is considered cured with minimal risk of recurrence)
* Participant has a primary DSM diagnosis of general anxiety disorder (GAD), panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa. Subjects with comorbid GAD, social anxiety disorder (SAD), or panic disorder for whom MDD is considered the primary diagnosis are not excluded
* Participant has a length of current major depressive episode (MDE) \>24 months despite adequate treatment
* Participant has failed more than 2 treatments with a different pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Screening until follow-up phase (up to 12 months)
Secondary outcomes:
measure: Participants Leeds Sleep Evaluation Questionnaire (LSEQ) Score
timeFrame: Day 2, 11, 29, 31, 42
measure: Computerized Cognitive Test Battery: ISLT (Verbal Learning and Memory) Test
timeFrame: Day 1, 2 , 5, 6, 10 and 11
measure: Computerized Cognitive Test Battery: Detection (DET) Test
timeFrame: Day 1, 2 , 5, 6, 10 and 11
measure: Computerized Cognitive Test Battery: Identification (IDN) Test
timeFrame: Day 1, 2 , 5, 6, 10 and 11
measure: Computerized Cognitive Test Battery: One Back (OBK) Test
timeFrame: Day 1, 2 , 5, 6, 10 and 11
measure: Computerized Cognitive Test Battery: Groton Maze Learning Test (GMLT)
timeFrame: Day 1, 2 , 5, 6, 10 and 11
measure: Polysomnography (PSG) Objective Assessment of Latency To Persistent Sleep
timeFrame: Day 1 to 2, 5 to 6 and 10 to 11
measure: Subjective Assessment of Latency To Persistent Sleep
timeFrame: Women of childbearing potential (WOCBP): Day 2, 11 and follow up visit (Day 13 and 24); Males and women of non-childbearing potential (WONCBP): Day 2, 11, 29 and follow up visit (Day 31 and 42)
measure: PSG Objective Assessment of Total Sleep Time
timeFrame: Day 1 to 2, 5 to 6 and 10 to 11
measure: Subjective Assessment of Total Sleep Time
timeFrame: Women of childbearing potential (WOCBP): Day 2, 11 and follow up visit (Day 13 and 24); Males and women of non-childbearing potential (WONCBP): Day 2, 11, 29 and follow up visit (Day 31 and 42)
measure: PSG Objective Assessment of Wake Time After Sleep Onset (WASO)
timeFrame: Day 1 to 2, 5 to 6 and 10 to 11
measure: Subjective Assessment of Wake Time After Sleep Onset (WASO)
timeFrame: Women of childbearing potential (WOCBP): Day 2, 11 and follow up visit (Day 13 and 24); Males and women of non-childbearing potential (WONCBP): Day 2, 11, 29 and follow up visit (Day 31 and 42)
measure: Inventory of Depressive Symptomatology-clinician Rated 30 (IDSC30) Score and Structured Interview Guide for Hamilton Depression Scale (SIGH-D) (as combined SIGHD-IDS)
timeFrame: Day 1, 11, 29, 31 and 42
measure: Quick Inventory of Depressive Symptoms-16 (QIDS-SR16) Score
timeFrame: Day 1, 11, 29, 31 and 42
measure: Ruminative Response Scale (RRS) Score
timeFrame: Day 1, 11 and 29
measure: Changes in Major Depressive Disorder (MDD)-related Biomarkers
timeFrame: Day 1, 11 and 29
measure: Plasma concentrations for JNJ-42847922
timeFrame: Day 1, 2, 6, 11 and 29
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Brussel
country: Belgium
city: Duffel
country: Belgium
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Schwerin
country: Germany
city: Leiden
country: Netherlands
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: