UMIN-CTR Clinical Trial

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

Premenstrual syndrome and premenstrual dysphoric disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Shiga University of Medical Science

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2017

Year

10

Month

01

Day

Last modified on

2021

Year

02

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033564