ABILIFY for the Adolescent Bipoloar I Mania Indication of Tool Effectiveness Evaluation Strategy

Study identification

• EU PAS number:
  EUPAS6083
• Study ID:
  23794
• Official title and acronym:
  ABILIFY for the Adolescent Bipoloar I Mania Indication of Tool Effectiveness Evaluation Strategy
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Cyprus

  Denmark

  Germany

  Ireland

  Italy

  Norway

  Portugal

  Slovenia

  Spain

  Sweden

  United Kingdom
• Study description:
  ABILIFY® (aripiprazole) is a drug indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older. It was approved by the European Commission on January 24th 2013. For reasons of conciseness, the indication throughout this protocol is termed adolescent bipolar I mania.As part of marketing authorisation approval, the ABILIFY® risk management plan (RMP) requires distribution of two Risk Minimisation (RM) communication tools, additional to the SmPC, to Healthcare Providers (HCPs) prescribing ABILIFY® for the adolescent bipolar I mania indication.These tools are a Healthcare Provider Frequently Asked Questions Brochure (HCP FAQ) and a Patient / Caregiver Information Brochure (PCIB). The purpose of the HCP FAQ is to clearly explain to prescribers or other HCPs involved in patient treatment the need to carefully consider the indicated age range, dose, and duration of treatment before prescribing ABILIFY® for the adolescent bipolar I mania indication. Furthermore, vigilance is urged in the on-going evaluation of weight gain, EPS, and ADRs related to somnolence and fatigue. A PCIB is available for physicians to give to their patients (and their caregivers) to help them better understand and recognise specific ADRs. The EU-RMP committed Otsuka Pharmaceutical Europe Ltd., as the marketing authorisation holder (MAH), to evaluate the effectiveness of these additional RM activities (i.e. the RM tools and their distribution) for the adolescent bipolar I mania indication.
• Study status:
  Finalised

Research institutions and networks

Institutions

Drug safety, Risk management & regulatory Practice, Pope Woodhead & Associates (PWA)

United Kingdom

Study timelines

Date when funding contract was signed

Planned:21/10/2013

Actual:21/10/2013

Study start date

Planned:30/07/2014

Actual:11/11/2014

Data analysis start date

Planned:04/01/2016

Actual:04/01/2016

Date of final study report

Planned:30/12/2016

Actual:23/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

OTSUKA PHARMACEUTICALS EUROPE LIMITED/LUNDBECK

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)