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

Major Depressive Disorder Clinical Trial

— GZPHBLT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04447430
• Other study ID #: GuangzhouPHBLT
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2020
• Source: Guangzhou Psychiatric Hospital
• Contact: Kangguang Lin, MD,PhD
• Phone: 13560360144
• Email: klin[@]connect.hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 ß-adrenergic blockers, melatonin, or St. John's wort; thyroid function test results inconsistent with normal pregnancy

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
China	Guangzhou Brain Hospital (Guangzhou Huiai Hospital)	Guanzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Psychiatric Hospital	The Third Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in depressive symptoms from baseline	Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD)	Week2;Week6
Secondary	Changes in anxious symptoms from baseline	anxious symptoms will be measured by the Hamilton Anxiety Scale(HAMA)	week 2; week 6