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Light Therapy to Improve Symptoms in Pregnant Women With Major Depressive Disorder

Bright Light Therapy in Pregnant Women With Major Depressive Disorder: a Randomized, Double-blind, Placebo-Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04447430
Acronym
GZPHBLT
Enrollment
140
Registered
2020-06-25
Start date
2020-06-12
Completion date
2021-12-30
Last updated
2020-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Light therapy; Major Depressive Disorder; Pregnancy

Brief summary

This study will investigate the effectivenss of bright light therapy(10000 lux white)on pregnant women with major depression disorder.

Detailed description

Depression during pregnancy is a common and high impact disease.Children who are exposed to maternal depression during pregnancy have a higher risk of adverse birth outcomes, such as low birth weight, and more often show cognitive, emotional and behavioral problems.Therefore, early detection and prompt treatment of depression during pregnancy can benefit both mother and child.However, the window of opportunity in pregnancy is small and from the perspective of the child postponement is in fact non-treatment. Psychotherapy might take a long time to be effective and do not work for all people. Further, the safety of pharmacological treatment for pregnant women with depression is still a big concern .Psychiatric medication use for depression in pregnancy may also pose a risk of fetal growth retardation and preterm delivery, as well as withdrawal symptoms in the new born. Therefore, investigating non-pharmacological approaches to treating depression during pregnancy is urgent and relevant, for both mother and child. Preliminary evidence shows that bright light therapy (BLT) is an effective treatment for pregnant women with depression based on several theoretical and clinical considerations, with effect size around 0.45 and without adverse effects to the new born. In this study we aim to investigate the effectiveness of BLT on pregnant women with major depression.

Interventions

treat patients with bright light, 30 min per day, 7 times per week, over 6 weeks

treat patients with dim red light, 30 min per day, 7 times per week, over 6 weeks

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University
CollaboratorOTHER
Guangzhou Psychiatric Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Women; 18\ 45 years of age; medically healthy, with normal ocular function; 13\ 28 weeks pregnancy; DSM-V diagnosis of major depressive disorder HAMD score ≥18

Exclusion criteria

DSM-V defined bipolar disorder、schizophrenia、schizoaffective disorder,anxiety disorders; substance Use Disorders; substance use within the last 6 months; suicidal ideation, suicidal attempt, suicide behavior, and attempted suicide; being treated by the light therapy; with antidepressant in recent 2 months; Multiple pregnancy; Any obstetrical care or medications for physical disorders that might confound treatment results; current use of β-adrenergic blockers, melatonin, or St. John's wort; thyroid function test results inconsistent with normal pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Changes in depressive symptoms from baselineWeek2;Week6Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD)

Secondary

MeasureTime frameDescription
Changes in anxious symptoms from baselineweek 2; week 6anxious symptoms will be measured by the Hamilton Anxiety Scale(HAMA)

Countries

China

Contacts

Primary ContactKangguang Lin, MD,PhD
klin@connect.hku.hk13560360144
Backup ContactTao Liu, MD
liutaolp@163.com15017554527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026