Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063092) titled 'THE LIVED EXPERIENCE OF ADULT JAPANESE EPILEPSY PATIENTS WITH EMOTIONAL OR MENTAL DIFFICULTIES AND OF SPOUSES/PARTNERS' on Sept. 29.

Study Type: Observational

Primary Sponsor: Institute - UCB Japan Co., Ltd.

Condition: Condition - Epilepsy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Primary objective: -To characterize the types of psychiatric symptoms experienced by adults with epilepsy in Japan and to describe the impact on QoL and daily functioning for both patients and spouses/partners.

Secondary objectives: -To explore the experiences and factors that influence whether adults with epilepsy and their spouses/partners discuss psychiatric symptoms during routine epilepsy consultations. -To describe the baseline demographic and clinical characteristics of the patients with epilepsy and their spouses or partners. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old

- Patients who currently or recently (within the past 6 months) experienced psychiatric symptoms associated with epilepsy, or organic (including symptomatic) mental disorders. These symptoms include, but are not limited to, mood changes, anxiety, hallucinations, or behavioral changes that are recognized by the treating physician or the patient themselves as psychiatric distress related to epilepsy. - Patients had a spouse or partner during that period. - Patients aged 18 years or older. - Patients who are currently employed. - Patients who agree to undergo a semi-structured interview and provide informed consent for audio recording.

- Spouses or partners whose spouse or partner is a patient with epilepsy experiencing psychiatric symptoms. - Spouses or partners aged 18 years or older. - Spouses or partners whose spouse or partner with epilepsy meets the patient inclusion criteria of this study. - Spouses or partners who agree to undergo a semi-structured interview and provide informed consent for audio recording. Key exclusion criteria - - Patients who have a developmental and epileptic encephalopathy (DEE). - Patients who have high seizure burden (>=1 seizure per week). - Patients who are students. - Patients who consider that participation in the study may negatively affect their current medical condition. - Patients employed by UCB and its affiliates. - Patients diagnosed with Autism Spectrum Disorder or Attention-Deficit/Hyperactivity Disorder. - Patients who had a confirmed diagnosis of psychiatric symptoms before being diagnosed with epilepsy.

- Spouses or partners who are students. - Individuals who are the parents of the patient. - Individuals employed by UCB and its affiliates. Target Size - 20

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 08 Month 25 Day Date of IRB - 2026 Year 09 Month 16 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2027 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072001

Disclaimer: Curated by HT Syndication.