Invesigator-initiated phase 2 study to evaluate efficacy and safety of pyridoxamine in patients with premenstrual symdromes (PMS) and premenstrual dysphoric disorder (PMDD)
- Conditions
- Premenstrual Syndrome and Premenstrual Dysphoric DisorderD011293, D065446
- Registration Number
- JPRN-jRCT2021200026
- Lead Sponsor
- Takeda Takashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 105
1. Provisional registration
(1) A patient with written informed consent
(2) A patient diagnosed with PMDD based on the DSM-5 diagnostic criteria for PMDD or diagnosed as having moderate and severe psychiatric symptoms associated with PMS based on the ACOG diagnostic criteria for PMS
(3) A patient with moderate to severe suspected PMS or suspected PMDD on the Premenstrual Symptoms Questionnaire (PSQ) assessment
(4) A patient over 20 years of age and under 45 years of age at the time of obtaining informed consent.
(5) A patient who is able to attend outpatient department throughout the study period
(6) A patient with a regular menstrual cycle between 25 and 38 days.
(7) A patient who agrees to use appropriate contraception on a regular basis from the time of informed consent throughout the study period.
(8) A patient who meets predetermined criteria as assessed by Daily Record of Severity of Problems (DRSP; ePRO or EDC between Visit 0 and Visit 2). However, if the criteria are not met solely by the degree of social disability, such patient will be additionally observed for another cycle.
2. Full registration
(9) A patient who meets predetermined criteria as assessed by Daily Record of Severity of Problems (DRSP; ePRO or EDC between Visit 2 and Visit 3)
(1) A patient who took oral contraceptives or hormone preparations containing estrogen and progesterone within 30 days prior to informed consent.
(2) A patient who was treated with antidepressants (tricyclics, tetracyclics, SSRIs, SNRIs, NaSSA) or herbal medicines within 2 weeks prior to informed consent
(3) A patient who is taking vitamin B6-containing preparations or supplements, dried chestberry extracts, aminophylline, theophylline, choline theophylline, levodopa, oxytocin-containing preparations, folic acid-containing preparations, typical antipsychotics (butyrophenones, phenothiazines, benzamides), anti-anxiety medications (Bbenzodiazepines, serotonergics), or any of the ADHD medications (methylphenidate, atomoxetine, guanfacine) , since obtaining informed consent,
(4)A patients who does not agree that the dosing regimen of atypical antipsychotics (serotonin and dopamine blockers, multimodal antipsychotics, and dopamine partial agonists), sleep medications (benzodiazepines, non-benzodiazepines, melatonin receptor agonists, and orexin receptor antagonists), and antiepileptic drugs cannot be changed during the study period.
(5) A patient who is expected to use two or more sleep medications (benzodiazepines, non-benzodiazepines, melatonin receptor agonists, or orexin receptor antagonists) during the study
(6)A patient with a diagnosis of schizophrenia, bipolar disorder, depressive disorders other than PMDD, anxiety, or obsessive-compulsive disorder
(7) A patient diagnosed with bipolar I disorder, bipolar II disorder, depression / major depressive disorder, and taking medications.
(8) A patient who had a seizure in the last 6 months up to the time of informed consent (Visit 0), if there are complications of epilepsy,
(9) A patient with malignant tumor, or treated for malignant tumor within 5 years before informed consent.
(10) A patient who is pregnant or breastfeeding, or who wishes to become pregnant during study period, at the time of informed consent.
(11) A patient who, in the opinion of the principal investigator/sub-investigators, is at high risk for self-harm, suicidal ideation or other symptoms that could result in poor treatment compliance, inability to complete the study, obstacles to study participation, or negative impact on safety assessments
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method