Clinical trial NCT03737474: A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder
Official title: A Multi-center, Open-label Trial to Assess the Long-term Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-09
Enrollment: 248
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From baseline to week 52
Secondary outcomes:
measure: Mean Changes From Baseline in Montgomery Åsberg Depression Rating Scale(MADRS) Total Scores at Week 52(LOCF)
timeFrame: Baseline and Week 52(LOCF)
measure: The Proportion of Subjects Who Score 1 or 2 on the Clinical Global Impression-Improvement(CGI-I) Scale at Week 52(LOCF)
timeFrame: Baseline and Week 52 (LOCF)
measure: Mean Changes From Baseline in Clinical Global Impression-Severity of Illness(CGI-S) at Week 52(LOCF)
timeFrame: Baseline and Week 52 (LOCF)
measure: Mean Changes From Baseline in Hamiliton Depression Rating Scale(HAM-D) Item Total Scores at Week 52(LOCF)
timeFrame: Baseline and Week 52 (LOCF)
measure: Mean Changes From Baseline in Sheehan Disability Scale (SDS) Scores at Week 52(LOCF)
timeFrame: Baseline and Week 52 (LOCF)
Other outcomes:
Locations:
city: Shirakawa
country: Japan
facility: Nanko-kokorono clinic
Study officials:
References: