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

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

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

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: bright light; Device: dim red light

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510370
      • Recruiting
      • Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
      • Contact: Kangguang Lin, MD，PhD; Phone Number: 13560360144; Email: klin@connect.hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bright light group; treat patients with bright light (10000 lux)	Device: bright light; treat patients with bright light, 30 min per day, 7 times per week, over 6 weeks
Placebo Comparator: dim red light group; treat patients with dim red light (100 lux)	Device: dim red light; treat patients with dim red light, 30 min per day, 7 times per week, over 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in depressive symptoms from baseline	Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD)	Week2;Week6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in anxious symptoms from baseline	anxious symptoms will be measured by the Hamilton Anxiety Scale(HAMA)	week 2; week 6

Collaborators and Investigators

• Sponsor: Guangzhou Psychiatric Hospital
• Collaborators: The Third Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Kangguang Lin, MD,PhD, Guangzhou Brain Hospital(Guangzhou Psychiatric Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Light therapy; Major Depressive Disorder; Pregnancy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major
• Other Study ID Numbers: GuangzhouPHBLT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No