Major Depressive DisorderPhase 2/3NCT03697603

A Study of Brexpiprazole in Patients With Major Depressive Disorder

A Phase 2/3 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

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. Read more about this study

Who is it for?: Ages 20 to 64 years
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?: Yes, some participants may receive a placebo
How many people: 740 participants
Where: 1 siteJapan
Study dates: 30 Jul 2018to 4 Jul 2022
Phase: Phase 2/3
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 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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
Fukushima

Other trials in Japan

About this study

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

Conditions: Major Depressive Disorder
Being tested: Brexpiprazole, Placebo
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
Also called REXULTI
Tablets, Oral, once daily, 14 weeks
PlaceboDrug
Tablets, Oral, once daily, 14 weeks

Study groups in NCT03697603
Study group	Role	What they receive
Brexpiprazole 1mg	Experimental	Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI Receives: Drug: Brexpiprazole
Brexpiprazole 2mg	Experimental	Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI Receives: Drug: Brexpiprazole
Placebo	Placebo comparator	Tablets, Oral, once daily, 14 weeks Receives: Drug: Placebo

What is being measured

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

Mean Changes From Baseline (Week 8 of the Antidepressant Treatment Period [Phase A]) in the MADRS Total Scores at Week 6 of the Double-blind Period (Phase B).
The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consisted 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 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.The mean changes were compared between antidepressant treatments and brexpiprazole as adjunctive therapy.
Measured: Baseline (the end of Phase A), at completion of administration (Week 6).

Secondary outcomes (1)

CGI-I Improvement Rate at Week 6 of the Double-blind Period (Phase B)
Clinical Global Impression - Improvement (CGI-I) improvement rate: the proportion of participants who score 1 or 2 on the CGI-I scale at Week 6 of the double-blind period (Phase B).
The CGI-I Scale was a clinician-rated scale which assessed the total improvement of the participant'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 indicated worse condition.
Measured: Baseline (the end of Phase A), at completion of administration (Week 6).

Timeline

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

30 Jul 20184 Jul 2022

First posted5 Oct 2018
Study start30 Jul 2018
Primary completion6 Jun 2022
Study completion4 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 740 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03697603
Sponsor's protocol ID: 331-102-00058
Status last verified: Mar 2024
First submitted: 24 Jul 2018
Last updated: 9 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03697603
Acronym / sponsor ID: 331-102-00058
Conditions: Major Depressive Disorder
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 740 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Jul 2018 (actual)
Primary completion: 6 Jun 2022 (actual)
Study completion: 4 Jul 2022 (actual)
First posted: 5 Oct 2018 (actual)
Results: Posted 9 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Brexpiprazole 1mg	Experimental	Drug: BrexpiprazoleTablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI
Brexpiprazole 2mg	Experimental	Drug: BrexpiprazoleTablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI
Placebo	Placebo comparator	Drug: PlaceboTablets, Oral, once daily, 14 weeks

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (14 listed)

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
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BrexpiprazoleAlso: REXULTITablets, Oral, once daily, 14 weeks	Drug	Brexpiprazole 1mg, Brexpiprazole 2mg
PlaceboTablets, Oral, once daily, 14 weeks	Drug	Placebo

Primary outcome

Mean Changes From Baseline (Week 8 of the Antidepressant Treatment Period [Phase A]) in the MADRS Total Scores at Week 6 of the Double-blind Period (Phase B).
Time frame: Baseline (the end of Phase A), at completion of administration (Week 6).
The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consisted 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 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.The mean changes were compared between antidepressant treatments and brexpiprazole as adjunctive therapy.

1 secondary outcome

CGI-I Improvement Rate at Week 6 of the Double-blind Period (Phase B)
Time frame: Baseline (the end of Phase A), at completion of administration (Week 6).

Results and safety

Results posted to the registry on 9 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brexpiprazole 1 mg	250	238
Brexpiprazole 2 mg	246	219
Placebo	244	232

Primary outcome: Mean Changes From Baseline (Week 8 of the Antidepressant Treatment Period [Phase A]) in the MADRS Total Scores at Week 6 of the Double-blind Period (Phase B).

Time frame: Baseline (the end of Phase A), at completion of administration (Week 6).. Mean (Standard Error). Unit: Units on a scale

Measure	Brexpiprazole 1 mg n = 248	Brexpiprazole 2 mg n = 245	Placebo n = 243
Value	-8.5 (0.47)	-8.2 (0.47)	-6.7 (0.47)

Brexpiprazole 2 mg vs Placebo: Mean Difference (Final Values): -1.4 (95% CI -2.7 to -0.1), p = 0.0312, MMRM
Brexpiprazole 1 mg vs Placebo: Mean Difference (Final Values): -1.7 (95% CI -3.0 to -0.4), p = 0.0089, MMRM

Population analysed: FAS (Same as Baseline Analysis Population Description)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were monitored from signing of the informed consent form until post-treatment observation period for up to 30 days (±5 days) after the final day of study medication administration (end of trial date [final day of observation]).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brexpiprazole 1 mg	3 of 250 (1.2%)	108 of 250 (43.2%)	0 of 250
Brexpiprazole 2 mg	3 of 246 (1.2%)	153 of 246 (62.2%)	0 of 246
Placebo	2 of 244 (0.8%)	92 of 244 (37.7%)	0 of 244

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

Related trials for Major Depressive Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 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 4 inclusion and 14 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 9 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 9 Aug 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?

Mean Changes From Baseline (Week 8 of the Antidepressant Treatment Period [Phase A]) in the MADRS Total Scores at Week 6 of the Double-blind Period (Phase B). (time frame: Baseline (the end of Phase A), at completion of administration (Week 6).). 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 NCT03697603.

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 9 Aug 2024.