Major depressive disorder
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Outpatients, or inpatients at the time of informed consent whose treatment status can be successfully shifted to outpatient status before enrollment in the antidepressant treatment period 2) Male and female patients 20 - 64 years of age (at the time of informed consent) 3) Patients who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial 4) Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode," and whose current episode has persisted for at least 8 weeks
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening 2) Sexually active male subjects or sexually active female subjects of childbearing potential, who will not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after the final IMP administration. For birth control, 2 of the following methods must be used: vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide. 5) Patients with a treatment history showing that all antidepressants (including those not used for the current major depressive episode) cannot be tolerated 6) Patients with a history of electroconvulsive therapy 7) Patients with a diagnosis of any of the following diseases according to DSM-5 a) Neurocognitive disorders b) Schizophrenia spectrum and other psychotic disorders c) Bipolar and related disorders d) Feeding and eating disorders e) Obsessive-compulsive disorder f) Panic disorder g) Posttraumatic stress disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Montgomery Asberg Depression Rating Scale (MADRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Clinical Global Impression -Global Improvement (CGI-I), Clinical Global Impression -Severity of Illness (CGI-S), Hamilton Depression Rating Scale (HAM-D), Sheehan Disability Scale (SDS), The Montgomery Asberg Depression Rating Scale Self-assessment (MADRS-S) | — |
Countries
Japan
Contacts
Public ContactDrug Information Center
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed