Comparative Effectiveness and Safety of Selective Serotonin Reuptake Inhibitors in Adult Attention-Deficit/Hyperactivity Disorder and comorbid depression (ASSURE-Extend)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105096
• EU PAS number:
  EUPAS103757
• Study ID:
  105096
• Official title and acronym:
  Comparative Effectiveness and Safety of Selective Serotonin Reuptake Inhibitors in Adult Attention-Deficit/Hyperactivity Disorder and comorbid depression (ASSURE-Extend)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders. Recently, more and more cases of ADHD persisting into adulthood or new-onset ADHD at adulthood suggest that a new approach is needed to manage ADHD. Unlike children, adults can have many deficits in higher-level executive functioning and emotional control and have many comorbid diseases due to diverse environmental exposures. Establishing treatment strategies according to comorbidities in ADHD patients is important, but the related evidence is weak. Most of Adult with ADHD also have many comorbidities such as anxiety disorder, depressive disorder, substance abuse, and autism spectrum disorder. 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.16 Although the first-line treatment for ADHD and depressive disorder is recommended in different guidelines, the evidence for effectiveness and safety evaluation of concomitant use of those drugs is sparse. Therefore, in this study, we aimed to evaluate the real-world evidence for comparative effectiveness and safety of the co-use of selective serotonin reuptake inhibitors (SSRIs), the fist recommended drug for depression, in ADHD patients (Adolescent ADHD and SSRI Use in Real-world Data – Extend to Adult: ASSURE Extend study). We also aimed to evaluate the outcome systemically through comparison between user vs non-user, between SSRI ingredient level as head-to-head study.
• Study status:
  Finalised

Research institution and networks

Institutions

Ajou University

Study timelines

Date when funding contract was signed

Planned: 01/02/2023

Actual: 01/02/2023

Study start date

Planned: 01/02/2023

Actual: 15/02/2023

Data analysis start date

Planned: 01/02/2023

Actual: 28/02/2023

Date of final study report

Planned: 30/04/2023

Actual: 30/05/2023

Sources of funding

Other

More details on funding

Health Insurance Assessment and Review Services

Study protocol

Initial protocol

Protocol_v1

Regulatory

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