UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058981 |
|---|---|
| Receipt number | R000067342 |
| Scientific Title | Internet survey on the prevalence of constipation in patients with schizophrenia and depression - CONSIDER survey |
| Date of disclosure of the study information | 2025/09/12 |
| Last modified on | 2025/09/03 18:50:49 |
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Basic information
Public title
Internet survey on the prevalence of constipation in patients with schizophrenia and depression - CONSIDER survey
Acronym
Internet survey on the prevalence of constipation in patients with schizophrenia and depression - CONSIDER survey
Scientific Title
Internet survey on the prevalence of constipation in patients with schizophrenia and depression - CONSIDER survey
Scientific Title:Acronym
Internet survey on the prevalence of constipation in patients with schizophrenia and depression - CONSIDER survey
Region
| Japan |
Condition
Condition
schizophrenia, depression
Classification by specialty
| Gastroenterology | Psychosomatic Internal Medicine | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Constipation is a common gastrointestinal disorder that impairs quality of life, and it has been reported to frequently complicate with schizophrenia and depression. An online survey will be conducted to investigate the prevalence of constipation, its severity, its impact on quality of life, and treatment status among patients with schizophrenia and depression.
Basic objectives2
Others
Basic objectives -Others
Constipation is a commonly recognized gastrointestinal disorder that causes abnormalities in bowel movements and has been reported to impair quality of life (QOL). Schizophrenia and depression are representative mental disorders, and constipation has been reported to occur frequently in patients with these disorders. In addition, constipation has been reported to occur frequently as a side effect of medications used to treat these disorders. An online survey will be conducted to investigate the prevalence of constipation in patients with schizophrenia and depression, the severity of constipation, its impact on QOL, and treatment status.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Exploratory examination of the following indicators
Quality of Life (SF-8)
Work Productivity (WPAI)
Constipation Scoring System (CSS)
Stool consistency (Bristol Stool Form Scale)
Constipation status (type of constipation, presence or absence of urge to defecate, presence or absence of abdominal distension, etc.)
Treatment status and satisfaction with constipation, preferences for medication administration methods, expectations and concerns regarding medications
Stratified analysis of patient background and factors associated with constipation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People with schizophrenia or depression, as well as members of the general public, who are registered with Cross Marketing Inc.'s research cooperation panel and have agreed to participate in this survey.
Key exclusion criteria
Nothing in particular
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Yoneda |
Organization
EA Pharma
Division name
Medical Science Group, Medical Dept.
Zip code
104-0042
Address
Sumitomo Irifune Bldg, 2-1-1, Irifune, Chuo-ku, Tokyo 104-0042, Japan
TEL
080-5900-4282
shinji_yoneda@eapharma.co.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Yoneda |
Organization
EA Pharma Co., Ltd.
Division name
Medical Science Group, Medical Dept.
Zip code
104-0042
Address
Sumitomo Irifune Bldg, 2-1-1, Irifune, Chuo-ku, Tokyo 104-0042, Japan
TEL
080-5900-4282
Homepage URL
shinji_yoneda@eapharma.co.jp
Sponsor or person
Institute
EA Pharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamauchi Clinic Research Ethics Committee
Address
1-15-9 Jiyugaoka, Meguro-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
| 2025 | Year | 09 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An online survey will be conducted to investigate the prevalence of constipation among patients with schizophrenia and depression, the severity of constipation, its impact on quality of life, and treatment status.
Management information
Registered date
| 2025 | Year | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067342
