UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061867 |
|---|---|
| Receipt number | R000070793 |
| Scientific Title | Association between premenstrual disorders and aggressive behavior during psychiatric hospitalization: a prospective observational study |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/11 13:22:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on menstruation and changes in behavior in psychiatric inpatients
Acronym
A study on menstruation and changes in behavior in psychiatric inpatients
Scientific Title
Association between premenstrual disorders and aggressive behavior during psychiatric hospitalization: a prospective observational study
Scientific Title:Acronym
Association between premenstrual disorders and aggressive behavior during psychiatric hospitalization: a prospective observational study
Region
| Japan |
Condition
Condition
Premenstrual disorders in women with psychiatric disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between the menstrual cycle and behavior during hospitalization among female patients admitted to a psychiatric hospital.
Basic objectives2
Others
Basic objectives -Others
Prospective observational study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in behavior during hospitalization, including agitation and interpersonal conflicts
Key secondary outcomes
Frequency, type, and severity of behavioral changes during hospitalization, and behavioral changes during the premenstrual period and other periods
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
Female
Key inclusion criteria
Women newly admitted to a psychiatric hospital, aged 18 years or older, who are able to understand the study and provide informed consent.
Key exclusion criteria
Patients with an expected hospital stay of less than one week, no menstruation during the past 12 months (including postmenopausal women), pregnancy, inability to adequately understand explanations or questionnaires in Japanese, or those judged by their attending psychiatrist to be unsuitable for participation in the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mioko |
| Middle name | |
| Last name | Furuya |
Organization
Tokyo Metropolitan Matsuzawa Hospital
Division name
Department of Psychiatry
Zip code
156-0057
Address
2-1-1, Kamikitazawa, Setagaya-ku, Tokyo, Japan
TEL
03-3303-7211
furuya.mioko@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Mioko |
| Middle name | |
| Last name | Furuya |
Organization
Tokyo Metropolitan Matsuzawa Hospital
Division name
Department of Psychiatry
Zip code
156-0057
Address
2-1-1, Kamikitazawa, Setagaya-ku, Tokyo, Japan
TEL
03-3303-7211
Homepage URL
furuya.mioko@tmd.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Matsuzawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Public Health, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokyo Metropolitan Hospital Organization
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
Tel
042-300-5111
tmerp_erb@tmhp.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 | 06 | Month | 15 | 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
| 2026 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study of women newly admitted to a psychiatric hospital. The study aims to investigate the relationship between the menstrual cycle and behavior during hospitalization, including agitation and interpersonal problems. Around 10 days after admission, participants will undergo a brief interview and complete a questionnaire regarding menstruation, and information on the menstrual cycle during hospitalization will be collected. In addition, clinical information routinely recorded during usual care and records of behavior during hospitalization will be collected. Eligible patients who provide informed consent will be consecutively enrolled during the study period.
Management information
Registered date
| 2026 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070793
