Chronotherapy for Perinatal Depression

No longer recruiting at 3 trial locations

Overseen By Samantha Meltzer-Brody, MD,MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Must not be taking: Photosensitizing medications

Disqualifiers: Psychosis, Bipolar, Seizure, Migraines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach called Personalized Integrated Chronotherapy to assist pregnant women with depression, with or without anxiety. The treatment combines light therapy and sleep schedule adjustments to improve mood by targeting body clock and sleep patterns. Participants will receive either usual care (medication and/or talk therapy) or usual care plus this new therapy to determine which is more effective. The trial seeks expectant mothers diagnosed with major depressive disorder in their third trimester who are currently managing depression symptoms. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could enhance mental health during pregnancy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that usual care, which may include medication, will be part of the study. It's best to discuss your specific situation with the trial coordinators.

What prior data suggests that this Personalized Integrated Chronotherapy is safe for expectant mothers?

Research has shown that bright light therapy, a key component of Personalized Integrated Chronotherapy (PIC), has been studied for safety in treating depression during and after pregnancy. A small initial study on bright light therapy found that participants handled it well, with no major side effects reported, indicating its safety during this period. Other aspects of PIC, such as adjusting and stabilizing sleep patterns, do not involve medication and are generally considered safe, though specific data on them is limited. As this is an early-stage trial, the treatment remains under study, but components like bright light therapy have demonstrated safety in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about personalized integrated chronotherapy for perinatal depression because it combines traditional care methods like medications and talk therapy with an innovative approach using bright light therapy. Unlike standard treatments that focus mainly on medication and psychotherapy, this method includes exposure to bright light, which is thought to help regulate sleep-wake cycles and mood. This non-invasive addition could potentially offer faster symptom relief and improve overall well-being for new mothers, making it a promising new avenue in the treatment of perinatal depression.

What evidence suggests that Personalized Integrated Chronotherapy might be an effective treatment for perinatal depression?

Research has shown that bright light therapy, a key component of Personalized Integrated Chronotherapy (PIC), can assist individuals with perinatal depression. In this trial, participants in the Personalized Integrated Chronotherapy group will receive usual care along with a bright light box for morning use. One study found that bright light therapy improved symptoms for many patients, though it did not explain the mechanism. This therapy involves exposure to light similar to natural sunlight, which may enhance mood and sleep patterns. While experts continue to study its effectiveness for pregnant women, it offers a promising non-drug option for managing depression. The integrated approach also includes personalized sleep adjustments to help balance the body's internal clock, potentially further improving mood. ^{2 6 7 8 9}

Who Is on the Research Team?

Kristina M Deligiannidis, MD

Principal Investigator

Northwell Health

Samantha Meltzer-Brody, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a pregnant woman aged 18-45 with major depression.

Exclusion Criteria

I started taking antidepressants within the last 4 weeks.

Bipolar disorder (because sleep restriction can increase risk of conversion to mania)

Current employment as night shift worker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either usual care or Personalized Integrated Chronotherapy (PIC) during the 3rd trimester of pregnancy and postpartum

28 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Integrated Chronotherapy

Trial Overview

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.

How Is the Trial Designed?

Group I: Personalize Integrated Chronotherapy Experimental Treatment 1 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 Care Active Control 1 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).

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

Published Research Related to This Trial

In a 26-week study involving 99 children aged 6 to 15 with neurodevelopmental disorders, melatonin significantly reduced sleep onset latency by an average of 36.7 minutes, showing sustained effects even after treatment ended.

Melatonin treatment also led to improvements in temper upon waking and reduced sleepiness after awakening, with no significant adverse events reported after 16 weeks, indicating it is a safe long-term option for managing sleep problems in these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term melatonin treatment for the sleep problems and aberrant behaviors of children with neurodevelopmental disorders. Yuge, K., Nagamitsu, S., Ishikawa, Y., et al.[2022]

In a study of 194 bipolar depressed patients, over 60% responded positively to a treatment combining total sleep deprivation and light therapy (TSD + LT), indicating its potential efficacy for depression.

The study found that chronotype, or whether a person is a 'morning' or 'evening' type, significantly influenced treatment response, with evening-type patients showing higher rates of improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronotype influences response to antidepressant chronotherapeutics in bipolar patients. Dallaspezia, S., Suzuki, M., Clara, L., et al.[2019]

In a 12-week trial involving 146 children with neurodevelopmental disorders, melatonin significantly reduced the time it took for children to fall asleep by an average of 37.5 minutes, while also increasing total sleep time by about 22.4 minutes according to parent-reported diaries.

While melatonin improved sleep onset, it resulted in earlier waking times and did not lead to significant improvements in child behavior or family functioning, indicating that while it is safe and tolerable, its overall impact on sleep quality may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial. Gringras, P., Gamble, C., Jones, AP., et al.[2022]

A follow-up study of 44 children with neurodevelopmental disabilities showed that long-term melatonin therapy was well-tolerated, with no adverse reactions or development of tolerance reported over a period of up to 3.8 years.

Caregivers noted significant improvements in sleep quality, which correlated with better health, behavior, and learning outcomes, suggesting that melatonin can be an effective treatment for children with treatment-resistant circadian rhythm sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness outcome of melatonin therapy in children with treatment-resistant circadian rhythm sleep disorders. Carr, R., Wasdell, MB., Hamilton, D., et al.[2013]

Chronotherapeutics, which involves manipulating sleep-wake cycles and light exposure, has shown promising antidepressant effects, particularly in challenging cases like bipolar depression, where traditional antidepressants often fail.

Recent research has clarified the mechanisms behind chronotherapeutics, linking its efficacy to changes in neurotransmitter systems and the biological clock, suggesting it can be effectively integrated into standard psychiatric treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidepressant chronotherapeutics for bipolar depression. Benedetti, F.[2023]

Chronotherapy, which includes strategies like light therapy and sleep deprivation, has been shown to effectively reduce depressive symptoms and improve recovery in patients with depression and bipolar disorder.

Recent research indicates that combining chronotherapeutic interventions with pharmacological treatments can enhance efficacy, leading to shorter hospital stays and fewer changes in medication prescriptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of chronotherapy on depressive symptoms. Evidence-based practice. Khalifeh, AH.[2018]

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