Trial Outcomes & Findings for Personalized Integrated Chronotherapy for Perinatal Depression (NCT NCT04364646)

NCT ID: NCT04364646

Last Updated: 2025-12-09

Results Overview

Change in the Hamilton Depression Rating Scale score (range=0-54, higher scores indicate more depressive symptoms), average baseline score was \~19 in both groups, and remission goal is a score of 7 or a change of \~12.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: change from baseline at 33 weeks of gestation
• Results posted on: 2025-12-09

Participant Flow

Participant milestones

Measure	Usual Care 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). Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Personalize Integrated Chronotherapy 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. Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
Overall Study STARTED	63	57
Overall Study COMPLETED	51	38
Overall Study NOT COMPLETED	12	19

Reasons for withdrawal

Measure	Usual Care 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). Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Personalize Integrated Chronotherapy 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. Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	7	14
Overall Study Protocol Violation	4	5

Baseline Characteristics

Personalized Integrated Chronotherapy for Perinatal Depression

Baseline characteristics by cohort

Measure	Usual Care n=63 Participants 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). Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Personalize Integrated Chronotherapy n=57 Participants 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. Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Total n=120 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=4 Participants	10 Participants n=50 Participants	18 Participants n=518 Participants
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=4 Participants	57 Participants n=50 Participants	120 Participants n=518 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Age, Continuous	33.2 years STANDARD_DEVIATION 4.4 • n=4 Participants	31.8 years STANDARD_DEVIATION 4.8 • n=50 Participants	32.4 years STANDARD_DEVIATION 4.6 • n=518 Participants
Sex: Female, Male Female	63 Participants n=4 Participants	57 Participants n=50 Participants	120 Participants n=518 Participants
Sex: Female, Male Male	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=4 Participants	46 Participants n=50 Participants	101 Participants n=518 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	1 Participants n=50 Participants	1 Participants n=518 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Asian	9 Participants n=4 Participants	9 Participants n=50 Participants	18 Participants n=518 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Black or African American	12 Participants n=4 Participants	6 Participants n=50 Participants	18 Participants n=518 Participants
Race (NIH/OMB) White	35 Participants n=4 Participants	37 Participants n=50 Participants	72 Participants n=518 Participants
Race (NIH/OMB) More than one race	4 Participants n=4 Participants	5 Participants n=50 Participants	9 Participants n=518 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=4 Participants	0 Participants n=50 Participants	3 Participants n=518 Participants
Region of Enrollment United States	63 participants n=4 Participants	57 participants n=50 Participants	120 participants n=518 Participants
Hamilton Depression Rating Scale Score	19.4 units on a scale STANDARD_DEVIATION 3.8 • n=4 Participants	19.4 units on a scale STANDARD_DEVIATION 3.2 • n=50 Participants	19.4 units on a scale STANDARD_DEVIATION 3.5 • n=518 Participants

PRIMARY outcome

Timeframe: change from baseline at 33 weeks of gestation

Change in the Hamilton Depression Rating Scale score (range=0-54, higher scores indicate more depressive symptoms), average baseline score was ~19 in both groups, and remission goal is a score of 7 or a change of ~12.

Outcome measures

Measure	Usual Care n=55 Participants 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). Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Personalize Integrated Chronotherapy n=46 Participants 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. Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
Change in Depressive Symptoms	1.6 units on a scale Standard Deviation 4.0	2.2 units on a scale Standard Deviation 4.5

PRIMARY outcome

Timeframe: change from baseline at 36 weeks of gestation

Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)

Outcome measures

Measure	Usual Care n=48 Participants 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). Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Personalize Integrated Chronotherapy n=43 Participants 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. Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
Change in Depressive Symptoms	3.0 units on a scale Standard Deviation 4.0	3.8 units on a scale Standard Deviation 5.2

PRIMARY outcome

Timeframe: change from baseline at 2 weeks postpartum

Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)

Outcome measures

Measure	Usual Care n=52 Participants 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). Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Personalize Integrated Chronotherapy n=40 Participants 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. Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
Change in Depressive Symptoms	5.5 units on a scale Standard Deviation 5.3	5.8 units on a scale Standard Deviation 5.6

PRIMARY outcome

Timeframe: change from baseline at 6 weeks postpartum

Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)

Outcome measures

Measure	Usual Care n=51 Participants 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). Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Personalize Integrated Chronotherapy n=38 Participants 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. Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
Change in Depressive Symptoms	5.2 units on a scale Standard Deviation 5.7	5.9 units on a scale Standard Deviation 5.4

PRIMARY outcome

Timeframe: change from baseline at 18 weeks postpartum

Score on the Hamilton Depression Rating Scale (range=0-54, higher scores indicate more depressive symptoms)

Outcome measures

Measure	Usual Care n=47 Participants 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). Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Personalize Integrated Chronotherapy n=37 Participants 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. Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
Change in Depressive Symptoms	6.4 units on a scale Standard Deviation 5.0	7.1 units on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: change from baseline at 36 weeks pregnancy

Time of salivary dim light melatonin onset (DLMO)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: change from baseline at 6 weeks postpartum

Time of salivary dim light melatonin onset (DLMO)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: change from baseline at 33 weeks of pregnancy

time of sleep onset and sleep offset measured with wrist actigraphy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: change from baseline at 36 weeks of pregnancy

time of sleep onset and sleep offset measured with wrist actigraphy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: change from baseline at 2 weeks postpartum

time of sleep onset and sleep offset measured with wrist actigraphy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: change from baseline at 6 weeks postpartum

time of sleep onset and sleep offset measured with wrist actigraphy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: change from baseline at 18 weeks postpartum

time of sleep onset and sleep offset measured with wrist actigraphy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 weeks postpartum

infant sleep-wake patterns will be measured with one week of ankle actigraphy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 weeks postpartum

We will examine associations between salivary melatonin levels and melatonin levels in breast milk

Outcome measures

Outcome data not reported

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Personalize Integrated Chronotherapy

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=63 participants at risk 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). Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Personalize Integrated Chronotherapy n=57 participants at risk 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. Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
Reproductive system and breast disorders hospital admission	0.00% 0/63 • adverse events were assessed using the SAFTEE symptom checklist instrument at the following study visits: Visit 2 - baseline Visit 3 - 33 weeks of gestation Visit 4 - 36 weeks of gestation Visit 5 - 2 weeks postpartum Visit 6 - 6 weeks postpartum Visit 7 - 18 weeks postpartum We also collected adverse event data if participants contacted us about an AE between visits.	1.8% 1/57 • Number of events 1 • adverse events were assessed using the SAFTEE symptom checklist instrument at the following study visits: Visit 2 - baseline Visit 3 - 33 weeks of gestation Visit 4 - 36 weeks of gestation Visit 5 - 2 weeks postpartum Visit 6 - 6 weeks postpartum Visit 7 - 18 weeks postpartum We also collected adverse event data if participants contacted us about an AE between visits.

Other adverse events

Measure	Usual Care n=63 participants at risk 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). Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.	Personalize Integrated Chronotherapy n=57 participants at risk 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. Personalized Integrated Chronotherapy: Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
Pregnancy, puerperium and perinatal conditions pregnancy complications	25.4% 16/63 • Number of events 18 • adverse events were assessed using the SAFTEE symptom checklist instrument at the following study visits: Visit 2 - baseline Visit 3 - 33 weeks of gestation Visit 4 - 36 weeks of gestation Visit 5 - 2 weeks postpartum Visit 6 - 6 weeks postpartum Visit 7 - 18 weeks postpartum We also collected adverse event data if participants contacted us about an AE between visits.	28.1% 16/57 • Number of events 24 • adverse events were assessed using the SAFTEE symptom checklist instrument at the following study visits: Visit 2 - baseline Visit 3 - 33 weeks of gestation Visit 4 - 36 weeks of gestation Visit 5 - 2 weeks postpartum Visit 6 - 6 weeks postpartum Visit 7 - 18 weeks postpartum We also collected adverse event data if participants contacted us about an AE between visits.

Additional Information

Katherine M. Sharkey, MD, PhD

Center for Sleep and Circadian Rhythms, AHWFB

Phone: 336-716-4657

Email: katherine.sharkey@advocatehealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place