Post-authorization safety study (PASS) on extrapyramidal symptoms in patients treated with Abilify Maintena® in Germany


Aripiprazole intramuscular (IM) depot formulation (Abilify Maintena®) is a long-acting injectable atypical antipsychotic drug for the treatment of patients with schizophrenia, reducing overall symptoms and lowering the risk of relapse. The drug is available in Germany since June 2014.
Extrapyramidal symptoms (EPS) are a well-known adverse drug reaction of antipsychotic drugs. Although EPS occur less often in second generation atypical antipsychotics compared to first generation typical antipsychotics, EPS have a significant impact on subjective tolerability and adherence to antipsychotic therapy in addition to impacting global functioning and quality of life. In order to assess the risk of EPS of Aripiprazole IM depot formulation, a post-authorization safety study (PASS) based on claims data from the German Pharmacoepidemiological Research Database (GePaRD) has been requested by the European Medicines Agency (EMA).
The study aims to investigate incidence as well as the risk factors associated with development of EPS, in patients receiving Aripiprazole IM depot formulation for the first time (new users) under every day conditions, applying a cohort design that will cover the years 2014 to 2018. The study will also be conducted in Sweden and Italy.

Funding period

Begin:   June 2016
End:   December 2020


  • H. Lundbeck A/S


 Jonas Reinold