Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otsuka Pharmaceutical Co., Ltd.
Age
20–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Male and female patients ≥ 20 to \< 65 years of age (at the time of informed consent)
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
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
You may not be if
Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening
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.
Patients with a treatment history showing that all antidepressants (including those not used for the current major depressive episode) cannot be tolerated
Patients with a history of electroconvulsive therapy
Patients with a diagnosis of any of the following diseases according to DSM-5
1. Neurocognitive disorders
2. Schizophrenia spectrum and other psychotic disorders
3. Bipolar and related disorders
4. Feeding and eating disorders
5. Obsessive-compulsive disorder
6. Panic disorder
7. Posttraumatic stress disorder
Clareo Health | A Study of Brexpiprazole in Patients With Major Depressive Disorder
