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Major Depressive DisorderPhase 3NCT03737474

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

A Phase 3 study testing Brexpiprazole in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
Brexpiprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
1 siteJapan
Study dates
4 Oct 2018to 13 Apr 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Rollover subjects
  • Outpatients
  • 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
  • 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
  • Subjects with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode"
  • New subjects
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  • Outpatients
  • Male and female patients ≥ 65 years of age (at the time of informed consent)
  • 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
  • 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

Who cannot join

  • Rollover subjects
  • Female subjects who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at baseline
  • 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.
  • Subjects who experience a change to the manic state in the antidepressant treatment period of the double-blind trial
  • Subjects who are discovered to not meet the inclusion criteria or to fall under any of the exclusion criteria in the doubleblind trial
  • Subjects who showed marked noncompliance with the IMP treatment in the double-blind trial (subjects whose IMP compliance rates are < 65% between prescribed visits)
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  • New subjects
  • 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.
  • Patients with a treatment history showing that all antidepressants (also 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
  • Neurocognitive disorders
  • Schizophrenia spectrum and other psychotic disorders
  • Bipolar and related disorders
  • Feeding and eating disorders
  • Obsessive-compulsive disorder
  • Panic disorder
  • Posttraumatic stress disorder

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Nanko-kokorono clinic

    Shirakawa

Other trials in Japan

About this study

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

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.

Being tested
Brexpiprazole
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrexpiprazoleDrug

    2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily

Study groups in NCT03737474
Study groupRoleWhat they receive
BrexpiprazoleExperimental2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily
Receives: Drug: Brexpiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)

    A treatment-emergent adverse event (TEAE) was defined as an AE that started after start of investigational medicinal product (IMP) treatment.

    Measured: From baseline to week 52

Secondary outcomes (5)

  1. Mean Changes From Baseline in Montgomery Åsberg Depression Rating Scale(MADRS) Total Scores at Week 52(LOCF)

    The MADRS was a clinician-rated scale which evaluated the level of depression.The MADRS consists of 10 items assessed apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item was scored from 0 to 6, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 60, with higher scores indicating worse condition.

    Measured: Baseline and Week 52(LOCF)

  2. The Proportion of Subjects Who Score 1 or 2 on the Clinical Global Impression-Improvement(CGI-I) Scale at Week 52(LOCF)

    The CGI-I Scale was clinician-rated scale which assessed 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.

    Measured: Baseline and Week 52 (LOCF)

  3. Mean Changes From Baseline in Clinical Global Impression-Severity of Illness(CGI-S) at Week 52(LOCF)

    The CGI-S Scale was a clinician-rated scale which assessed how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.

    Measured: Baseline and Week 52 (LOCF)

  4. Mean Changes From Baseline in Hamiliton Depression Rating Scale(HAM-D) Item Total Scores at Week 52(LOCF)

    The HAM-D was a clinician-rated scale which evaluated the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on. Each item was scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 53 , with higher score indicating worse condition.

    Measured: Baseline and Week 52 (LOCF)

  5. Mean Changes From Baseline in Sheehan Disability Scale (SDS) Scores at Week 52(LOCF)

    SDS Scale was a patient-rated scale which assessed the degree of impairment for each of 3 items ("work/school," "social life," and "family life/home responsibilities") on a 11-point scale ranging from 0 to 10. The mean SDS score was the mean of scores for 3 items. Higher scores indicate worse condition.

    Measured: Baseline and Week 52 (LOCF)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2018
  2. Study start4 Oct 2018
  3. Primary completion17 Mar 2021
  4. Study completion13 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03737474
Sponsor's protocol ID
331-102-00059
Status last verified
Nov 2023
First submitted
29 Jul 2018
Last updated
29 Apr 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

Publications

  • Kato M, Shiosakai M, Kuwahara K, Iba K, Shimada Y, Saito M, Sekine D, Aoki K, Shiomi Y, Higuchi T. A Multicenter, Open-Label Study to Evaluate the Long-term Safety and Efficacy of Adjunctive Brexpiprazole 2 mg Daily in Japanese Patients with Major Depressive Disorder. CNS Drugs. 2024 Dec;38(12):1003-1016. doi: 10.1007/s40263-024-01124-w. Epub 2024 Oct 18.

    PubMed 39424742

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brexpiprazole in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) (time frame: From baseline to week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03737474, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.

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