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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029369
Receipt No. R000033564
Scientific Title Relationship between family expressed emotion (EE) and symptomatic relapse in premenstrual syndrome (PMS) /premenstrual dysphoric disorder (PMDD) patients
Date of disclosure of the study information 2017/10/01
Last modified on 2018/10/05

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Basic information
Public title Relationship between family expressed emotion (EE) and symptomatic relapse in premenstrual syndrome (PMS) /premenstrual dysphoric disorder (PMDD) patients
Acronym EE and symptomatic relapse in PMS/PMDD
Scientific Title Relationship between family expressed emotion (EE) and symptomatic relapse in premenstrual syndrome (PMS) /premenstrual dysphoric disorder (PMDD) patients
Scientific Title:Acronym EE and symptomatic relapse in PMS/PMDD
Region
Japan

Condition
Condition Premenstrual syndrome and premenstrual dysphoric disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the hypothesis that high EE of a family member/partner is associated with higher risk of symptomatic relapse after achieving remission in PMS/PMDD patient.
Basic objectives2 Others
Basic objectives -Others association study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relapse-free survival
Key secondary outcomes Change in PMS/PMDD symptoms assessed by Penn Daily Symptom Report (DSR) score.
Subjective change in symptoms, improvements in understanding of disease, subjective change in communication with family member/partner at the end of the study period.
Change in EE of family member/partner assessed by Five Minute Speech Sample (FMSS) since first assessment.

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
20 years-old <=
Age-upper limit
40 years-old >
Gender Female
Key inclusion criteria Patient and family member/partner who have come to our hospital during the study period and meet all of the following criteria.

[PMS/PMDD patient]
1. Agrees to be treated for PMS/PMDD
2. Has PMS/PMDD symptoms according to DSR and Sheehan Disability Scale (SDISS) (Pre-menstrual SDR score of 80 and above, score is increased by more than 50% of the post-menstrual score, and meets 1 or more items in SDISS)
3. Is above 20 years old and under 40 years old at the time of agreement
4. Has a regular menstrual cycle (Menstrual cycle is between 25 and 38 days and fluctuation is 7 days or less, duration of bleeding is within 7 days and fluctuation is 2 days or less)
5. Has a family member/partner who has lived in the same household for more than 3 months prior to agreement to participate in the study, who plans to live in the same household until the end of the study, and who is willing to attend the outpatient sessions
6. Is able to sign the agreement form by free will (both the patient and family member/partner)

[Family member/partner]
1. Is a family member/partner of the patient who meets the inclusion criteria
Key exclusion criteria [PMS/PMDD patient]
1. Meets the diagnostic criteria of schizophrenia, depression, or drug/medication-induced depression according to DSM-5 or has a history of mania episode and meets the diagnostic criteria for bipolar disorder
2. Requires continued intake of oral contraceptives and/or other hormonal agents
3. Requires steroids and/or other anti-inflammatory medications
4. Possess hypothyroidism, Cushing Disease, systemic lupus erythematosus or any other disease which has risk for depressive symptoms
5. Any patients whom the study staff or investigator find inappropriate to include in the study

[Family member/partner]
None
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Aoi Kawamura
Organization Shiga University of Medical Science
Division name Department of Psychiatry
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2111
Email kaoi0211@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Kuriyama
Organization Shiga University of Medical Science
Division name Department of Psychiatry
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2111
Homepage URL
Email kenichik@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Investigate the relationship between EE of a family member/partner assessed by FMSS and symptomatic relapse in PMS/PMDD patient assessed by DSR score.

Management information
Registered date
2017 Year 10 Month 01 Day
Last modified on
2018 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033564

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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