Clinical trial NCT04447430: Light Therapy to Improve Symptoms in Pregnant Women With Major Depressive Disorder
Official title: Bright Light Therapy in Pregnant Women With Major Depressive Disorder: a Randomized, Double-blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Light therapy; Major Depressive Disorder; Pregnancy
Lead sponsor: Guangzhou Psychiatric Hospital
Sponsor class: OTHER_GOV
Collaborators: name: The Third Affiliated Hospital of Guangzhou Medical University
First posted: 2020-06-25
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in depressive symptoms from baseline
timeFrame: Week2;Week6
Secondary outcomes:
measure: Changes in anxious symptoms from baseline
timeFrame: week 2; week 6
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
state: Guangdong
Study officials:
affiliation: Guangzhou Brain Hospital(Guangzhou Psychiatric Hospital)
name: Kangguang Lin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: