Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581029
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
assessment of psychiatric problems in pediatric SLE and their caregivers evaluate the possible risk factors of psychiatric problems such as peer victimization academic performance fatigue self-esteem and quality of life
Detailed Description:
Juvenile-onset systemic lupus erythematosus jSLE is a rare but severe multisystem autoimmune disease which may cause significant damage disability and death Juvenile SLE patients constitute 15-20 of all SLE cases Compared to the adult SLE jSLE patients have higher morbidity and mortality rates Renal cardiovascular and neuropsychiatric NP involvements are the most important reasons for morbidity and mortality
Therefore knowledge of common mental illnesses such as major depressive disorder MDD and anxiety disorders in cSLE may be limited Establishing the prevalence of MDD and anxiety in cSLE is important as comorbidity rates of these disorders may be increased in cSLE for several reasons First the diagnosis of a serious physical health condition confers psychological vulnerability to feelings of sadness helplessness stress and worry about the future9 For some individuals such symptoms warrant further evaluation and may persist beyond the initial adjustment period and reach clinical significance requiring therapeutic intervention SLE carries a patient-treatment burden similar to other chronic diseases Such treatment burden places susceptible individuals at risk of psychiatric disorder Second although depressed mood may present in the absence of active CNS disease it may also occur as a symptom of neuropsychiatric c SLE NPSLE yielding clinically significant treatment implications Third treatment of SLE with known depressogenic medications like steroid may lead to depressive symptom elevation or exacerbate a co-morbid primary MDD Moreover among patients with depressed mood as a manifestation of NPSLE the initiation of steroid treatment may worsen depressive symptoms It is unclear whether such risks are observed in the cSLE population
Therefore knowledge of common mental illnesses such as major depressive disorder MDD and anxiety disorders in cSLE may be limited Establishing the prevalence of MDD and anxiety in cSLE is important as comorbidity rates of these disorders may be increased in cSLE for several reasons First the diagnosis of a serious physical health condition confers psychological vulnerability to feelings of sadness helplessness stress and worry about the future9 For some individuals such symptoms warrant further evaluation and may persist beyond the initial adjustment period and reach clinical significance requiring therapeutic intervention SLE carries a patient-treatment burden similar to other chronic diseases Such treatment burden places susceptible individuals at risk of psychiatric disorder Second although depressed mood may present in the absence of active CNS disease it may also occur as a symptom of neuropsychiatric c SLE NPSLE yielding clinically significant treatment implications Third treatment of SLE with known depressogenic medications like steroid may lead to depressive symptom elevation or exacerbate a co-morbid primary MDD Moreover among patients with depressed mood as a manifestation of NPSLE the initiation of steroid treatment may worsen depressive symptoms It is unclear whether such risks are observed in the cSLE population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None