LEONIDaS Caregivers Study

Depression Clinical Trial

— LEONIDaS  

Official title:

The LEONIDaS(Long Term Exploration of Outcomes From New Interventions in Dravet Syndrome) Caregivers Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05140122
• Other study ID #: R76178/RE001
• Status: Withdrawn
• Start date: October 26, 2023
• Est. completion date: October 26, 2023

Study information

• Verified date: December 2023
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Inability to provide informed written consent

• Another caregiver of the same individual with Dravet is already enrolled in the study

Related Conditions & MeSH terms

• Anxiety
• Depression
• Dravet Syndrome
• Epilepsies, Myoclonic
• Syndrome

Intervention

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

Other:
• Multiple
We will collect information on all forms of therapy or medical intervention taken by the caregiver and the person they care for.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Caregiver stress scores on the UW Caregiver Stress Scale	Higher scores indicate higher symptom levels (worse outcome)	Follow up at three years
Primary	Caregiver stress scores on the UW Caregiver Stress Scale	Higher scores indicate higher symptom levels (worse outcome)	Follow up at two years
Primary	Caregiver stress scores on the UW Caregiver Stress Scale	Higher scores indicate higher symptom levels (worse outcome)	Follow up at one year
Primary	Emotional processing biases on the Facial Expression Recognition Task (FERT)		Follow up at three years
Primary	Emotional processing biases on the Facial Expression Recognition Task (FERT)		Follow up at two years
Primary	Emotional processing biases on the Facial Expression Recognition Task (FERT)		Follow up at one year