Clinical trial NCT02476058 (phase 1, status: completed)
Conditions: major depressive disorder
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40
Drugs: jnj-42847922, diphenhydramine, placebo
SMILES: CN(C)CCOC(C1=CC=CC=C1)C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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