Overview
A Safety, Efficacy and Biomarker Study of JNJ-42847922 in Participants With Major Depressive Disorder
Status:
Completed
Completed
Trial end date:
2016-01-04
2016-01-04
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the safety and tolerability of JNJ-42847922 in participants with Major Depressive Disorder (MDD).Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janssen-Cilag International NVTreatments:
Diphenhydramine
Promethazine
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