A Safety, Efficacy and Biomarker Study of JNJ-42847922 in Participants With Major Depressive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-11

Study Completion Date

2016-01-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress

NCT02498392

Depressive Disorder Anxiety

COMPLETED PHASE2

A Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Participants With Major Depressive Disorder

NCT03374475

Depressive Disorder, Major

COMPLETED PHASE1

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

NCT03227224

Depressive Disorder, Major

COMPLETED PHASE2

A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression

NCT03559192

Depressive Disorder, Major

COMPLETED PHASE2

A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety Symptoms

NCT01582815

Major Depressive Disorder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

JNJ-42847922

JNJ-428479, 20 milligram (mg) capsule, orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.

Group Type EXPERIMENTAL

JNJ-42847922

Intervention Type DRUG

JNJ-428479, 20 milligram (mg) capsule, orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.

Diphenhydramine

Diphenhydramine 25 mg capsule, orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.

Group Type EXPERIMENTAL

Diphenhydramine

Intervention Type DRUG

Diphenhydramine 25 mg capsule, orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.

Placebo

Matching placebo (capsules containing neutral pellets), orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo (capsules containing neutral pellets), orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JNJ-42847922

JNJ-428479, 20 milligram (mg) capsule, orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.

Intervention Type DRUG

Diphenhydramine

Diphenhydramine 25 mg capsule, orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.

Intervention Type DRUG

Placebo

Matching placebo (capsules containing neutral pellets), orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No