Study using the App for premenstrual syndrome (PMS) or premenstrual dysphoric mood disorder (PMDD)

JRCT ID: jRCTs022240054

Registered date:27/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Premenstrual syndrome (PMS) or Premenstrual dysphoric mood disorder (PMDD)
• Date of first enrollment: 27/01/2025
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Duration of intervention with study device: 12 weeks (84 days, daily)
Study device (treatment-arm application)
Control device (control-arm application)

This study will involve assessments at 5 in-patients visits and interventions and evaluations via an application out-of-hospital. (e.g., at home) The study consists of a pre-observation period (two menstrual cycles) from informed consent and initial registration (Visit 1) to the day before randomization (Visit 3), a 12-week application intervention period (84 days from Visit 3), and a subsequent post-observation period (from the day after the end of the application intervention to Visit 5).

Outcome(s)

• Primary Outcome: The amount of change from baseline [late luteal phase ((III)CD-1 to CD-5) immediately before application intervention] in the mean DRSP total score during the third late luteal phase((VI)CD-1 to CD-5) after the start of the application intervention.

Secondary Outcome

1.The amount of change from baseline in the DRSP total score during the late luteal phase (the 5 days before menstruation) of each menstrual cycle after the start of the application intervention.
2.The amount of change from the maximum value (the highest score of the average score for 5 consecutive days) of the previous observation period in the mean value of the total score of the DRSP in the late luteal phase (the 5 days before menstruation) of each menstrual cycle after the start of the app intervention.
3.The amount of change from baseline in the DRSP psychiatric symptoms score during the late luteal phase (the 5 days before menstruation).
4.The amount of change from baseline in the DRSP physical symptoms score during the late luteal phase (the 5 days before menstruation).
5.The amount of change from baseline in the DRSP subscale score during the late luteal phase (the 5 days before menstruation).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Female

Include criteria

Patients who meet all the inclusion criteria and do not violate any of the exclusion criteria will be eligible. The menstrual cycle at the time of the initial registration will be designated as "Menstrual Cycle (I)", and subsequent menstrual cycles will be labeled in numerical order.

At primary enrollment
Subjects who meet all the following criteria at Visit 1 [Day 1 to Day 20 of Menstrual Cycle (I) ((I) CD1-20)] will be included:
1.Subjects who can understand the content of the study and who can provide written informed consent to participate in the study of their own free will.
2.Female subjects aged >= 18 and <= 45 years at the time of consent and are able to understand Japanese as well as their native language.
3.Subjects with a regular menstrual cycle ranging from 25 to 38 days.
4.Subjects who do not wish to become pregnant during the study period and agree to use appropriate contraception.
5.Subjects suspected of having moderate or more severe symptoms of PMS or PMDD at Visit 1 (to be determined by the principal investigator based on medical interviews, etc.).
6.Subjects who can make outpatient visits during the study period.
7.Subjects who own a smartphone compatible with the application used in this study and who can continue to use it during the study period.

At secondary enrollment
Subjects must meet all the following criteria at Visit 2 [Day 14 +- 3 of the Menstrual Cycle (II) ((II)CD14 +- 3)]
1.Subjects who meet all the following criteria based on the DRSP evaluation from Visit 1 to Visit 2:
aThe average daily score of 3 or more of the 21 items of PMS symptoms from 1a to 11d is >= 3 during the 5-day late luteal phase of Menstrual Cycle (I) [from 5 days to 1 day before the onset of the menstrual cycle (II) (II)CD-1 to CD-5].
bThe average daily score of 3 or fewer of the 21 items of PMS symptoms from 1a to 11d is <= 3 for all items during the 5-day mid follicular phase of the menstrual cycle (II) ((II)CD6 to CD10.
cImprovement of >= 30% in the average daily score of the 3 items or more among the 21 items of PMS symptoms from 1a to 11d from the luteal phase of Menstrual Cycle (I) (II-CD-1 to CD-5) to the follicular phase of Menstrual Cycle (II) (II-CD6 to CD10).
dDuring the late luteal phase of menstrual Cycle (I) [(II) CD-1 to CD-5], at least 1 of the 3 items assessing social impairment is rated as "mild (3 points)" or higher.

At randomized enrollment
Subjects must meet all the following criteria at Visit 3 [Day 14 +- 3 of Menstrual Cycle (III) ((III)CD14 +- 3)].
1.Subjects who meet all the following criteria based on the DRSP evaluation from Visit 2 to Visit 3:
aThe average daily scores of 3 or more of the 21 items of PMS symptoms from 1a to 11d of is >= 3 during the 5-day late luteal phase of Menstrual Cycle (II) ((III)CD-1 to CD-5).
bThe average daily score of each of the 21 items of PMS symptoms from 1a to 11d is <= 3 for all items during the 5-day mid-follicular phase of the menstrual cycle (III) ((III)CD6 to CD10.
cImprovement of >= 30% in the average daily score of the 3 items or more among the 21 items of PMS symptoms from 1a to 11d from the late luteal phase of Menstrual Cycle (II) ((III)-CD-1 to CD-5) to the mid-follicular phase of the menstrual Cycle (III) ((III)-CD6 to CD10).
dDuring the late luteal phase of menstrual Cycle (II) ((III) CD-1 to CD-5), at least 1 of the 3 items assessing social impairment is rated as "mild (3 points)" or higher.
2.Subjects diagnosed with moderate to severe PMS or PMDD by the principal investigator or sub-investigators based on the assessments and evaluations during the pre-observation period (Visit 1 and Visit 2).

Exclude criteria

Subjects who meet any of the following criteria will be ineligible.
1.Subjects whose therapies or medications used before and after participation in this study do not meet the conditions for medications, supplements, etc. specified in the restrictions on concomitant therapy (prohibited concomitant therapies, prohibited concomitant medications, restricted concomitant medications) as outlined in Section 11.8, or who are expected to be unable to comply with the specified conditions during the defined period, or who do not agree to adhere to the specified regulations.
2.Subjects currently using antidepressants (tricyclic, tetracyclic, SSRI, SNRI, NaSSA), typical antipsychotics (butyrophenones, phenothiazines, benzamides), atypical antipsychotics (serotonin-dopamine antagonists, multi-acting receptor-targeted antipsychotics, dopamine partial agonists), ADHD medications (methylphenidate, atomoxetine, guanfacine), and/or antiepileptic drugs.
3.Subjects with a history of antidepressant use within 1 year prior to obtaining consent.
4.Subjects diagnosed with schizophrenia, bipolar disorder, depressive disorders other than PMDD, major depressive disorder, anxiety disorders, or epilepsy, or those suspected of having any of these conditions, and who are deemed inappropriate as research subjects by the principal investigator or sub-investigators.
5.Subjects who are pregnant at the time of obtaining consent or those who wish to become pregnant during the study period.
6.Subjects who have previously participated in an interventional study using an application for PMS/PMDD.
7.Subjects who have participated in another clinical trial or interventional clinical research within 30 days prior to obtaining consent.
8.Subjects who are considered by the principal investigator or sub-investigator to be at high risk for ensuring the safety of the research subjects and the execution of the research itself, such as those unable to complete the study due to self-harm behavior or suicidal ideation, those whose participation is hindered by these factors, or those whose condition may affect safety assessments.
9.Subject considered inappropriate for the study by the investigator for any other reason.
10.Subjects who have not started menstruation at least twice within 12 weeks following the date of consent (from the date of consent to 84 days after the date of consent).

Related Information

• Primary Sponsor: Ogawa Mariko
• Secondary Sponsor: ASKA Pharmaceutical Co., Ltd.