Open-label Brexpiprazole fMRI Trial in Adults With Major... | NCT05504486

Studies
Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety

NCT05504486

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Status

Withdrawn

Last Update Posted

Jan 30, 2023Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Major Depressive Disorder (MDD)

Interventions

Brexpiprazole

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor strategic decision

Expanded Access Info

Start Date

Aug 29, 2022Estimated

Primary Completion Date

Mar 22, 2023Estimated

Completion Date

Apr 5, 2023Estimated

First Submitted Date

May 31, 2022

First Submission Date that Met QC Criteria

Aug 15, 2022

First Posted Date

Aug 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2023

Last Update Posted Date

Jan 30, 2023Actual

Name	Class
H. Lundbeck A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Brexpiprazole	Drug: Brexpiprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brexpiprazole	Drug	Oral tablet; take once daily; target daily dose of 2 mg	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in fMRI resting-state salience network community structure from baseline to post-treatment		Week 6

Secondary Outcomes

Measure	Description	Time Frame
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	Week 6
Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 65 year of age
Major Depressive Disorder (MDD) with symptoms of anxiety
Stable treatment with less than 50% improvement

Exclusion Criteria:

Contraindicated to perform fMRI scan
Previous exposure to brexpiprazole

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000591922	brexpiprazole

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided