Abilify Maintena PMS in Schizophrenia Patients or Bipolar... | NCT03386851

Studies
Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

NCT03386851

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Feb 14, 2022Actual

Enrollment

1,030Actual

Phase

Not provided

Conditions

Schizophrenia
Bipolar 1 Disorder

Interventions

Not provided

Countries

South Korea

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2016Actual

Primary Completion Date

May 25, 2021Actual

Completion Date

May 25, 2021Actual

First Submitted Date

Dec 22, 2017

First Submission Date that Met QC Criteria

Dec 22, 2017

First Posted Date

Dec 29, 2017Actual

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

Feb 10, 2022

Last Update Posted Date

Feb 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Not provided

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

This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: Ministry of Food and Drug Safety(MFDS) Notification).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,030Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR		until 28 days after discontinuation

Secondary Outcomes

Measure	Description	Time Frame
Mean change from baseline to last visit in Clinical Global Impression - Severity of Illness scale (CGI-S) score.		at least 12, 24 weeks interval from baseline
Clinical Global Impression - Improvement scale (CGI-I) score at the last visit		at least 12, 24 weeks interval from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with schizophrenia or bipolar 1 disorder
Patients who are prescribed Abilify Maintena® Injections treatment as per investigator's medical judgment
Patients giving written authorization to use their personal and health data and starting Abilify Maintena® Injections treatment after agreement is in place and investigators provide the explanation about objective and feature of the surveillance

Exclusion Criteria:

Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify Maintena® Injections
Elderly patients with dementia related psychosis
Patients who have been treated with Abilify Maintena® Injections
Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the Clinical Global Impression-Severity(CGI-S)
Patients participating in other clinical trial
All patients who in medical judgment of the investigator would not be appropriate for inclusion criteria in the surveillance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Schizophrenia or bipolar 1 disorder

Sampling Method

Non-Probability Sample

Type	Date	Date Unknown
Release	May 12, 2022
Reset	Feb 16, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 12, 2022			Feb 16, 2023

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided