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

Primary Purpose

Major Depressive Disorder

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

bright light

dim red light

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Light therapy; Major Depressive Disorder; Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Guangzhou Brain Hospital (Guangzhou Huiai Hospital)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bright light group

dim red light group

Arm Description

treat patients with bright light (10000 lux)

treat patients with dim red light (100 lux)

Outcomes

Primary Outcome Measures

Changes in depressive symptoms from baseline

Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD)

Secondary Outcome Measures

Changes in anxious symptoms from baseline

anxious symptoms will be measured by the Hamilton Anxiety Scale(HAMA)

Full Information

NCT ID

NCT04447430

First Posted

June 23, 2020

Last Updated

June 24, 2020

Sponsor

Guangzhou Psychiatric Hospital

Collaborators

The Third Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04447430

Brief Title

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

Acronym

GZPHBLT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 12, 2020 (Actual)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou Psychiatric Hospital

Collaborators

The Third Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Light therapy; Major Depressive Disorder; Pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

bright light group

Arm Type

Experimental

Arm Description

treat patients with bright light (10000 lux)

Arm Title

dim red light group

Arm Type

Placebo Comparator

Arm Description

treat patients with dim red light (100 lux)

Intervention Type

Device

Intervention Name(s)

bright light

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

dim red light

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in depressive symptoms from baseline

Description

Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD)

Time Frame

Week2;Week6

Secondary Outcome Measure Information:

Title

Changes in anxious symptoms from baseline

Description

anxious symptoms will be measured by the Hamilton Anxiety Scale(HAMA)

Time Frame

week 2; week 6

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kangguang Lin, MD,PhD

Phone

13560360144

Ext

18028619981

klin@connect.hku.hk

First Name & Middle Initial & Last Name or Official Title & Degree

Tao Liu, MD

Phone

15017554527

liutaolp@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kangguang Lin, MD,PhD

Organizational Affiliation

Guangzhou Brain Hospital(Guangzhou Psychiatric Hospital)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

City

Guanzhou

State/Province

Guangdong

ZIP/Postal Code

510370

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kangguang Lin, MD，PhD

Phone

13560360144

klin@connect.hku.hk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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