← Back to Search

Chronotherapy for Perinatal Depression

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks postpartum
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Depressive Symptoms
Secondary outcome measures
Change in Circadian Phase
Change in Sleep Timing
Infant sleep behavior
+1 more

Trial 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
1,508 Previous Clinical Trials
4,190,822 Total Patients Enrolled
5 Trials studying Postpartum Depression
120 Patients Enrolled for Postpartum Depression
Johns Hopkins UniversityOTHER
2,263 Previous Clinical Trials
14,822,945 Total Patients Enrolled
5 Trials studying Postpartum Depression
985 Patients Enrolled for Postpartum Depression
University of VirginiaOTHER
754 Previous Clinical Trials
1,244,853 Total Patients Enrolled
1 Trials studying Postpartum Depression
400 Patients Enrolled for Postpartum Depression

Media Library

Personalized Integrated Chronotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04364646 — N/A
Postpartum Depression Research Study Groups: Personalize Integrated Chronotherapy, Usual Care
Postpartum Depression Clinical Trial 2023: Personalized Integrated Chronotherapy Highlights & Side Effects. Trial Name: NCT04364646 — N/A
Personalized Integrated Chronotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04364646 — N/A
Postpartum Depression Patient Testimony for trial: Trial Name: NCT04364646 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this research program for volunteers?

"According to the website clinicaltrials.gov, this clinical trial is still recruiting participants. The original posting for this trial was on 11/2/2020, with the most recent edit on 10/17/2022."

Answered by AI

Who meets the qualifications to be a part of this research?

"This clinical trial is currently enrolling 220 participants that suffer from depression and are within the ages of 18 to 45. To be eligible, applicants must meet the following requirements: - Be pregnant women, ages 18-45 years old with a HAMD score of 14 or higher and a current DSM-5 diagnosis of major depressive disorder as determined with the Current Major Depression Module of the Structured Clinical Interview for DSM disorders (SCID-I/P)."

Answered by AI

Are patients who are 30 years or older able to join this trial?

"This particular study requires that patients be aged between 18-45. However, there are 265 other trials available for minors and 1176 for adults over the age of 65."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
North Carolina
Maryland
How old are they?
65+
18 - 65
What site did they apply to?
Rhode Island Hospital
University of North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

support research and support myself too.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

when / how often would travel to hospital be needed?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. University of North Carolina: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Personalized Integrated Chronotherapy for Perinatal Depression
Katherine M. Sharkey 2020. "Personalized Integrated Chronotherapy for Perinatal Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04364646.
All > Depression Raleigh > Treatment Resistant Depression
~5 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top