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Chronotherapy for Perinatal Depression
N/A
Waitlist Available
Led By Samantha Meltzer-Brody, MD
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Preexisting eye/skin disorders contraindicating light therapy
Use of photosensitizing medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 36 weeks pregnancy
Awards & highlights
Summary
This trial is testing whether a non-pharmacological treatment called Personalized Integrated Chronotherapy (PIC) can improve outcomes for pregnant women with depression and anxiety. The study will enroll expectant mothers who will be randomized to either: (a) usual care (UC, n = 110) or (b) PIC+UC (n = 110). PIC+UC will have pregnancy and postpartum components and will be administered via a personalized approach tailored to optimize the intervention based on each patient's individual circadian and sleep timing. The study will assess whether PIC is effective in improving mood symptoms and will also examine the target mechanisms by which
Who is the study for?
This trial is for pregnant women aged 18-45 with major depressive disorder, as diagnosed by a specific clinical interview and having a certain depression score. It's not for those with seizure disorders, night shift workers, substance abuse issues, high-risk pregnancies or other primary mental health diagnoses. Participants must speak and read English.
What is being tested?
The study tests Personalized Integrated Chronotherapy (PIC) plus usual care against usual care alone in treating perinatal depression. PIC includes bright light therapy, sleep phase advance, and sleep stabilization/restriction tailored to each patient's circadian rhythm.
What are the potential side effects?
Potential side effects of PIC may include increased risk of seizures if predisposed, mania in individuals with bipolar disorder history (excluded from the trial), eye strain or skin issues due to light therapy, and headaches or migraines triggered by bright light or lack of sleep.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have eye or skin conditions that prevent me from undergoing light therapy.
Select...
I am taking medication that increases my sensitivity to light.
Select...
I have a condition that causes seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 36 weeks pregnancy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 36 weeks pregnancy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Depressive Symptoms
Secondary study objectives
Change in Circadian Phase
Change in Sleep Timing
Infant sleep behavior
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Personalize Integrated ChronotherapyExperimental Treatment1 Intervention
Women in the integrated chronotherapy group receive usual care (medications and/or talk therapy, as above) and also receive a bright light box to sit with every morning for up to 60 minutes as prescribed by the study doctor.
Group II: Usual CareActive Control1 Intervention
Women in the usual care group receive medications and/or talk therapy. Sleep and light levels are monitored at home with wrist actigraphy during 3rd trimester of pregnancy (weeks 28-40) and weeks 2-6 and18 after the baby is born (postpartum weeks 2-6 and 18).
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillOTHER
1,543 Previous Clinical Trials
4,248,884 Total Patients Enrolled
5 Trials studying Postpartum Depression
120 Patients Enrolled for Postpartum Depression
Johns Hopkins UniversityOTHER
2,307 Previous Clinical Trials
14,861,751 Total Patients Enrolled
5 Trials studying Postpartum Depression
985 Patients Enrolled for Postpartum Depression
University of VirginiaOTHER
771 Previous Clinical Trials
1,284,139 Total Patients Enrolled
2 Trials studying Postpartum Depression
742 Patients Enrolled for Postpartum Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I started taking antidepressants within the last 4 weeks.I am a pregnant woman aged 18-45 with major depression.I have eye or skin conditions that prevent me from undergoing light therapy.I cannot participate because I do not speak or read English.I am taking medication that increases my sensitivity to light.I have a condition that causes seizures.I often get migraines or headaches triggered by bright light or lack of sleep.I am a pregnant woman aged 18-45 with major depression.I am a pregnant woman aged 18-45 with major depression.
Research Study Groups:
This trial has the following groups:- Group 1: Personalize Integrated Chronotherapy
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Postpartum Depression Patient Testimony for trial: Trial Name: NCT04364646 — N/A
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