Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06445933
Other study ID # 202309090RIPA
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 5, 2024
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source National Taiwan University Hospital
Contact HanYing Chen
Phone 886-930078287
Email hanyingchan@Hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Perinatal depression is a highly prevalent and serious health issue during pregnancy. According to statistics, approximately one out of every ten postpartum women experiences this condition. Symptoms can manifest as mood fluctuations or emotional lows. Unfortunately, these symptoms are often overlooked by patients themselves or misinterpreted by others as normal adjustments to the new role of motherhood. Consequently, timely assistance and support are frequently lacking. To address this, the investigators urgently need effective preventive measures for perinatal depression before it escalates. Recent research suggests that simple oral supplementation of vitamin B6 may help prevent and alleviate perinatal depression to some extent. Vitamin B6 plays several crucial roles in the body, including regulating neurotransmission and mental health. Therefore, it could contribute to maintaining emotional stability and psychological balance. In contemporary times, numerous screening methods for perinatal depression involve questionnaires. However, these methods presuppose an awareness of the possibility of perinatal depression. Individuals who are unaware of these questionnaires may go undetected. Hence, our aim is to investigate whether cardiac electrophysiology results obtained through a wearable device could offer a more objective evaluation of the status of perinatal depression. Our plan involves conducting a prospective study to delve deeper into the preventive and therapeutic effects of vitamin B6 on perinatal depression in pregnant women. Through systematic experiments and data analysis, the investigators aim to explore the impact of vitamin B6 dosage, duration, and timing of administration. Ultimately, the investigators hope to provide evidence-based recommendations and guidance for clinical practice. The investigators' goal is to offer new insights and methods to protect the mental health of expectant mothers, ensuring a pleasant and healthy pregnancy journey for each one.


Description:

The total expected number of participants is 120, with 60 in the experimental group and 60 in the control group. Participants in the experimental group will take Vitamin B6, while those in the control group will take a placebo that looks similar. To ensure the credibility of the study and reduce bias, the investigators will adopt a randomized double-blind design. The target population is pregnant women aged 20-50 years, in their 28th-30th week of pregnancy. Vitamin B6 is an FDA-approved Class A drug in the United States, with no evidence of any side effects on the fetus. A baseline blood sample to measure Vitamin B6 concentration will be taken during the 28th-30th week of pregnancy, and another sample will be taken upon admission for delivery for follow-up. To avoid blood glucose affecting Vitamin B6 levels, both blood samples will be taken after an 8-hour fast. The experimental group will take three 25mg Vitamin B6 tablets daily (75mg/day) from the 28th-30th week until the end of pregnancy, and two 25mg Vitamin B6 tablets daily (50mg/day) for one month after delivery. The control group will take three placebo tablets daily from the 28th week until the end of pregnancy, and two placebo tablets daily for one month after delivery. The placebo tablets contain starch and resemble the shape of the Vitamin B6 tablets. During each prenatal visit from the 28th week until the end of pregnancy, doctors will remind participants to take their medication. An electronic system at NTU Hospital will also remind participants weekly to take their medication. Postpartum, study staff will remind participants every two weeks by phone to continue taking Vitamin B6 or placebo. Participants will complete a postpartum depression questionnaire at the 6-week follow-up visit. The results of the postpartum depression questionnaire will be analyzed in relation to Vitamin B6 intake. The investigators currently plan to use linear and logistic regression analysis to examine the association between depression scores and Vitamin B6 concentration. Other possible statistical methods include: Chi-square, independent t-test, Mann-Whitney U test, and Fisher's exact test. A p-value below 5% will be considered statistically significant. Data will be analyzed using SPSS 20.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Pregnant women at 24-28 weeks of gestation - Without a personal history of depression, bipolar disorder, schizophrenia, or other mental health conditions. Exclusion Criteria: - Allergic to Vitamin B6

Study Design


Intervention

Combination Product:
Vitamin B6
The intervention is taking Vitamin B6 orally from recruitment around 24-28 gestational weeks to 6 weeks post-partum. 75mg/ day before delivery and 50mg/ day after delivery.
Placebo
Placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

References & Publications (1)

Khodadad M, Bahadoran P, Kheirabadi GR, Sabzghabaee AM. Can Vitamin B6 Help to Prevent Postpartum Depression? A Randomized Controlled Trial. Int J Prev Med. 2021 Oct 19;12:136. doi: 10.4103/ijpvm.IJPVM_240_19. eCollection 2021. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with GAD-2(General Anxiety Disorder-2) score=3 and EPDS(Edinburgh Postnatal Depression Scale)=10. The investigators would like to see if participants taken Vitamin B6 would have lowered incidence of having GAD-2(General Anxiety Disorder-2) score=3 or EPDS(Edinburgh Postnatal Depression Scale)=10. The maximum score for the GAD-2 is 6, and the minimum is 0. A higher score indicates a greater likelihood of anxiety. The maximum score for the Edinburgh Postnatal Depression Scale (EPDS) is 30, and the minimum is 0. A higher score indicates a greater likelihood of postnatal depression. 22 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT06348316 - Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies N/A
Completed NCT05322161 - Yoga in the NICU for Parents Study N/A
Withdrawn NCT03709004 - Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression N/A
Completed NCT06305325 - Coparenting Intervention to Prevent Postpartum Depression N/A
Not yet recruiting NCT05055674 - The Effects of Motherly on Postpartum Depression N/A
Enrolling by invitation NCT02323152 - PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK N/A
Not yet recruiting NCT01658098 - Prevalence of Postpartum Depression in Hospital Jose E. Gonzalez N/A
Completed NCT00961402 - The Effect of Exercise on Preventing PostPartum Depression Phase 2
Completed NCT01312883 - Mothers Avoiding Depression Through Empowerment Intervention Trial N/A
Completed NCT00360204 - Improving Health Outcomes for New Mothers and Babies Phase 3
Unknown status NCT00548743 - Translating Research Into Practice for Postpartum Depression N/A
Completed NCT04146025 - Nurtured in Nature N/A
Not yet recruiting NCT06442774 - MamaConecta: Digital Tool for Maternal Mental Health N/A
Recruiting NCT05137925 - Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum N/A
Not yet recruiting NCT05299398 - Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone Phase 1
Completed NCT04925765 - Virtual Reality Biofeedback for Postpartum Anxiety and Depression N/A
Recruiting NCT06053515 - Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication N/A
Completed NCT04037085 - Ketamine to Improve Recovery After Cesarean Delivery - Part 1 Phase 2
Completed NCT05059600 - A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting Phase 4
Completed NCT06136520 - The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression N/A