Safety outcomes of Selective Serotonin Reuptake Inhibitors in Adolescent Attention-Deficit/Hyperactivity Disorder (The ASSURE study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44894
• EU PAS number:
  EUPAS44893
• Study ID:
  44894
• Official title and acronym:
  Safety outcomes of Selective Serotonin Reuptake Inhibitors in Adolescent Attention-Deficit/Hyperactivity Disorder (The ASSURE study)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders of adolescents. In addition to ADHD, patients with ADHD also have many comorbidities such as anxiety disorder, depressive disorder, substance abuse, and autism spectrum disorder. Therefore, the American Academy of Pediatrics recommends that comorbidity evaluation be performed at least once when diagnosing ADHD as one of the key action statements in their 2019 clinical practice guideline. Especially, ADHD is closely related to depressive disorder. There are previous studies on high comorbidity rate, biological linkage or causality, and its clinical outcomes. When establishing a treatment strategy for ADHD patients with depression, the clinical hurdles for the use of antidepressants are concerns about changes in the patients’ condition (i.e., suicidality, etc.) and an increase in adverse effects. Although the first-line treatment for adolescent ADHD and depressive disorder is recommended in different guidelines, the evidence for safety evaluation of concomitant use of those drugs is sparse. Therefore, in this study, we aimed to evaluate the safety of the co-use of selective serotonin reuptake inhibitors (SSRIs), the first recommended drug for adolescent depression, in ADHD patients (Adolescent ADHD and SSRI Use in Real-world data: ASSURE study). We also aimed to evaluate the safety outcome within the SSRI class as a head-to-head study.
• Study status:
  Planned

Research institutions and networks

Institutions

Ajou University

Study timelines

Date when funding contract was signed

Planned: 01/07/2021

Study start date

Planned: 01/07/2021

Data analysis start date

Planned: 10/01/2022

Date of final study report

Planned: 31/07/2022

Sources of funding

Other

More details on funding

Health Insurance Review & Assessment Service, Ministry of Health &Welfare, Republic of Korea (grant number: HR16C0001), Bio Industrial Strategic Technology Development Program (20003883) funded by Ministry of Trade, Industry & Energy (MOTIE, Korea) (grant : 20005021), Bio Industrial Strategic Technology Development Program (20003883) funded by Ministry of Trade, Industry & Energy (MOTIE, Korea) (grant : 20003883)

Study protocol

Initial protocol

ASSURE_protocol_v1.0

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable