Overview

A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder

Status:
Completed

Trial end date:
2021-04-13

Target enrollment:
0

Participant gender:
All

Summary

This trial is a 52-week study to assess the safety of long-term use of brexpiprazole as adjunctive therapy in combination with an antidepressant.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Otsuka Pharmaceutical Co., Ltd.

Treatments:

Brexpiprazole

Criteria

Inclusion Criteria:

- Rollover subjects

1. Outpatients

2. Subjects who have completed the double-blind period of the double-blind trial and
can commence the treatment period of this trial within 28 days from the
completionof the double-blind period of the double-blind trial

3. Subjects 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. Subjects with a DSM-5 classification-based diagnosis of "major depressive
disorder, single episode" or "major depressive disorder, recurrent episode"

- New subjects

1. Outpatients

2. Male and female patients ≥ 65 years of age (at the time of informed consent)

3. Subjects 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" whose
current episode has persisted for at least 8 weeks

Exclusion Criteria:

- Rollover subjects

1. Female subjects who are pregnant or breastfeeding or who have positive pregnancy
test (urine) results at baseline

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.

3. Subjects who experience a change to the manic state in the antidepressant
treatment period of the double-blind trial

4. Subjects who are discovered to not meet the inclusion criteria or to fall under
any of the exclusion criteria in the doubleblind trial

5. Subjects who showed marked noncompliance with the IMP treatment in the
double-blind trial (subjects whose IMP compliance rates are < 65% between
prescribed visits)

- New subjects

1. Sexually active male subjects who will not agree to practice 2different 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.

2. Patients with a treatment history showing that all antidepressants (also
including those not used for the current major depressive episode) cannot be
tolerated

3. Patients with a history of electroconvulsive therapy

4. 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