A Study of Brexpiprazole in Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial to Assess the Efficacy and Safety of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697603
• Other study ID #: 331-102-00058
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 30, 2018
• Est. completion date: July 4, 2022

Study information

• Verified date: July 2022
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: July 4, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Brexpiprazole
Tablets, Oral, once daily, 14 weeks
• Placebo
Tablets, Oral, once daily, 14 weeks

Locations

Country	Name	City	State
Japan	Nanko-kokorono clinic	Fukushima

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean changes from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total scores at last visit of the double-blind period	The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.	Baseline and Week 14
Secondary	The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement (CGI-I) scale at Week 14	The CGI-I Scale is a clinician-rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7:0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.	Baseline and Week 14