Status:
COMPLETED
A Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Participants With Major Depressive Disorder
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to explore if the magnitude of treatment effect (JNJ-42847922; placebo) on symptoms of depression (as measured by Hamilton rating scale for depression-17 \[HDRS17\], Sleep...
Eligibility Criteria
Inclusion
- Have a body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m\^2) inclusive (BMI = weight/height\^2)
- Participants must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
- Population specific: Participant must meet Diagnostic and Statistical Manual of Mental Disorders - fifth edition (DSM-5) diagnostic criteria for MDD (international classification of diseases \[ICD\]-code F32.x and F33.x), without psychotic features, and confirmed by the Mini International Neuropsychiatric Interview (MINI) 7.0; have a Montgomery Asberg Depression Rating Scale (MADRS) total score greater than or equal to (\>=) 25 at screening and must not demonstrate a clinically significant change (that is, an improvement of greater than (\>) 20 percent (%) on their MADRS total score) from the screening to the second completion of MADRS by telephone at most 4 days before the baseline visit; Not currently receiving antidepressant drug therapy for \>= 2 weeks before screening
- Men who are sexually active with a women of childbearing potential (WOCBP) and have not had a vasectomy must agree to use a barrier method of birth control
- A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug
Exclusion
- Has failed more than 2 treatments (no more than 20 percent (%) response) with a differing pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode
- Has a diagnosis of Cushing's Disease, Addison's Disease, primary amenorrhea, or other evidence of significant medical disorders of the Hypothalamus pituitary adrenal (HPA) axis
- Is pregnant or breast feeding
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the planned first dose of study drug, or has participated in 2 or more interventional clinical studies in the previous 1 year, or is currently enrolled in an interventional study
- Participant is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03374475
Start Date
January 5 2018
End Date
April 29 2019
Last Update
April 27 2025
Active Locations (14)
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1
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
2
Artemis Institute for Clinical Research
San Marcos, California, United States, 92078
3
Qps-Mra, Llc
Miami, Florida, United States, 33143
4
SGS Phase 1 Unit AZ St-Maarten
Mechelen, Belgium, 2800