UMIN-CTR Clinical Trial

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	0
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	Terminated
Date of protocol fixation	2017 Year 08 Month 15 Day
Date of IRB	2017 Year 08 Month 18 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2019 Year 10 Month 15 Day
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	2021 Year 02 Month 24 Day

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