LEONIDaS Caregivers Study

NCT05140122 | Withdrawn

• 1 other identifier: R76178/RE001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dravet syndrome is a rare form of severe epilepsy that begins in the first year of life and is associated with frequent and/or prolonged seizures. Individuals with Dravet Syndrome often experience a range of comorbidities, including behavioral and developmental delays, movement and balance issues, sleep difficulties, chronic infections, and growth and nutritional issues. Patients with Dravet syndrome are at high risk of death due to SUDEP (Sudden Unexpected Death in Epilepsy), prolonged seizures, seizure-related accidents, and infections. Due to the severity of this condition, parents of children with Dravet syndrome are typically highly involved in their child's 24-hour care and this has a considerable impact on family life. Recent studies have highlighted the profound impact that such caregiving has on physical health, mental health, social function and financial resources. In particular, caregivers report high levels of stress and anxiety, fatigue, depression and social isolation. However, there is currently a lack of effective interventions to reduce the negative impact of caregiving on caregivers. The aim of this study is to prospectively study carers of individuals with Dravet syndrome to identify pharmacological and psychological factors that are associated with increased or decreased vulnerability to stress, depression and anxiety. Using a naturalistic, observational design the investigators will assess a cohort of Dravet Syndrome carers every six months for 3 years in order to further characterise trajectories of caregiver burden and the factors that influence this, including factors related to the person with Dravet syndrome (e.g. age, seizure frequency/severity, treatment/medications, comorbidities) and factors related to the carer and family environment (e.g. social engagement/isolation, fatigue, finances, relationships). The investigators will use both standardized questionnaires and a neurocognitive task (Facial Expression Recognition Task) to assess vulnerability to anxiety and depression. The study will be conducted online.

Conditions

Dravet Syndrome; Depression; Anxiety

Outcome Measures

Primary Outcomes (9)

• Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)

  Higher scores indicate higher symptom levels (worse outcome)

  Follow up at three years

• Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)

  Higher scores indicate higher symptom levels (worse outcome)

  Follow up at two years

• Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)

  Higher scores indicate higher symptom levels (worse outcome)

  Follow up at one year

• Caregiver stress scores on the UW Caregiver Stress Scale

  Higher scores indicate higher symptom levels (worse outcome)

  Follow up at three years

• Caregiver stress scores on the UW Caregiver Stress Scale

  Higher scores indicate higher symptom levels (worse outcome)

  Follow up at two years

• Caregiver stress scores on the UW Caregiver Stress Scale

  Higher scores indicate higher symptom levels (worse outcome)

  Follow up at one year

• Emotional processing biases on the Facial Expression Recognition Task (FERT)

  Follow up at three years

• Emotional processing biases on the Facial Expression Recognition Task (FERT)

  Follow up at two years

• Emotional processing biases on the Facial Expression Recognition Task (FERT)

  Follow up at one year

Study Arms (1)

Primary caregivers of individuals with Dravet Syndrome

Drug: Multiple; Other: Multiple

Interventions

Multiple DRUG

We will collect information on all medications taken by the caregiver and the person they care for.

Primary caregivers of individuals with Dravet Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caregivers of individuals with Dravet syndrome

You may qualify if:

• Willing and able to give informed consent for participation in the study
• Aged 18 years or above
• Primary caregiver of an individual with a medical history supporting a clinical diagnosis of Dravet syndrome
• Able to access the internet

You may not qualify if:

• Inability to provide informed written consent
• Another caregiver of the same individual with Dravet is already enrolled in the study

Sponsors & Collaborators

• University of Oxford: lead
• Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.: collaborator

MeSH Terms

Conditions

Epilepsies, Myoclonic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Catherine Harmer, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: December 1, 2021
• Study Start: October 26, 2023
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12