UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063092 |
|---|---|
| Receipt number | R000072001 |
| Scientific Title | THE LIVED EXPERIENCE OF ADULT JAPANESE EPILEPSY PATIENTS WITH PSYCHIATRIC SYMPTOMS AND OF SPOUSES/PARTNERS |
| Date of disclosure of the study information | 2026/09/29 |
| Last modified on | 2026/09/29 13:28:08 |
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Basic information
Public title
THE LIVED EXPERIENCE OF ADULT JAPANESE EPILEPSY PATIENTS WITH EMOTIONAL OR MENTAL DIFFICULTIES AND OF SPOUSES/PARTNERS
Acronym
LEAP-J study
Scientific Title
THE LIVED EXPERIENCE OF ADULT JAPANESE EPILEPSY PATIENTS WITH PSYCHIATRIC SYMPTOMS AND OF SPOUSES/PARTNERS
Scientific Title:Acronym
LEAP-J study
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
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.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thematic analysis outputs derived from semi-structured interviews regarding:
-Psychiatric symptom profile (focusing on lived experiences and situational contexts)
-Impact on life domains
-Coping strategies
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Patients with epilepsy>
- 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 of patients with epilepsy>
- 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 with epilepsy>
- 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 of patients with epilepsy>
- Spouses or partners who are students.
- Individuals who are the parents of the patient.
- Individuals employed by UCB and its affiliates.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Aikawa |
Organization
UCB Japan Co., Ltd.
Division name
Evidence Generation
Zip code
160-0023
Address
Shinjuku Grand Tower, 8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6864-7564
Tomonori.Aikawa@ucb.com
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Ashida |
Organization
Mebix, Inc.
Division name
Medical Science & Writing Group
Zip code
105-0001
Address
10F Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-4362-4500
Homepage URL
LEAP-J_sc@mebix.co.jp
Sponsor or person
Institute
UCB Japan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
UCB Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
Address
1-9-2 Nihonbashi-kayabacho, Chuo-ku, Tokyo
Tel
03-6777-1490
c-irb_ug@neues.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An exploratory cross-sectional qualitative study using web-based survey and semi-structured interviews.
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072001
