A Study of Brexpiprazole in Patients With Major Depressive Disorder
- Conditions
- Major depressive disorder
- Registration Number
- JPRN-jRCT2080223986
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
A statistically significant improvement was found in the primary endpoint of mean changes in MADRS total scores in the brexpiprazole 2 mg/day group compared with the placebo group, and a statistically significant improvement was also found in the brexpiprazole 1 mg/day group. The results of the secondary endpoints also supported the efficacy of brexpiprazole as adjunctive therapy to antidepressants (SSRI or SNRI). Brexpiprazole 1 and 2 mg/day had no major safety concerns and both doses were well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 740
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method