Major Depressive Disorder (MDD)Phase 4NCT05504486
Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
A Phase 4 study testing Brexpiprazole in people with Major Depressive Disorder (MDD), run by Otsuka Pharmaceutical Development & Commercialization, Inc..
Trial summary
The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Aug 2022to 5 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 year of age
- Major Depressive Disorder (MDD) with symptoms of anxiety
- Stable treatment with less than 50% improvement
Who cannot join
- Contraindicated to perform fMRI scan
- Previous exposure to brexpiprazole
About this study
Official title: A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety
The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Brexpiprazole
- Keywords
- Major depressive disorder (MDD), symptoms of anxiety, fMRI, brain networks, modularity, community structure, brexpiprazole, default mode network, salience network, central executive network, functional brain connectivity
- 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
Oral tablet; take once daily; target daily dose of 2 mg
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Brexpiprazole Receives: Drug: Brexpiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fMRI resting-state salience network community structure from baseline to post-treatment
Measured: Week 6
Secondary outcomes (3)
Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment.
Utilizing Jaccardized Czekanowski index
Measured: Week 6
Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.
Utilizing Jaccardized Czekanowski index
Measured: Week 6
Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment.
Utilizing Jaccardized Czekanowski index
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start29 Aug 2022 (estimated)
- Primary completion22 Mar 2023 (estimated)
- Study completion5 Apr 2023 (estimated)
Why it stopped: Sponsor strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504486
- Sponsor's protocol ID
- 331-201-00376
- Status last verified
- Jan 2023
- First submitted
- 31 May 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety
- ClinicalTrials.gov ID
- NCT05504486
- Acronym / sponsor ID
- 331-201-00376
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major depressive disorder (MDD), symptoms of anxiety, fMRI, brain networks, modularity, community structure, brexpiprazole, default mode network
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor strategic decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Study start
- 29 Aug 2022 (estimated)
- Primary completion
- 22 Mar 2023 (estimated)
- Study completion
- 5 Apr 2023 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BrexpiprazoleBrexpiprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 year of age
- Major Depressive Disorder (MDD) with symptoms of anxiety
- Stable treatment with less than 50% improvement
Key exclusion criteria (2 listed)
- Contraindicated to perform fMRI scan
- Previous exposure to brexpiprazole
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 |
|---|---|---|
| BrexpiprazoleOral tablet; take once daily; target daily dose of 2 mg | Drug | Arm 1 |
Primary outcome
Change in fMRI resting-state salience network community structure from baseline to post-treatment
Time frame: Week 6
3 secondary outcomes
Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment.
Time frame: Week 6
Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.
Time frame: Week 6
Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment.
Time frame: Week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brexpiprazole in people with Major Depressive Disorder (MDD), run by Otsuka Pharmaceutical Development & Commercialization, Inc..
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in fMRI resting-state salience network community structure from baseline to post-treatment (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2023.