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
1 other identifier
interventional
140
1 country
1
Brief Summary
This study will investigate the effectivenss of bright light therapy(10000 lux white)on pregnant women with major depression disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable major-depressive-disorder
Started Jun 2020
Shorter than P25 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2020
CompletedFirst Submitted
Initial submission to the registry
June 23, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedJune 25, 2020
June 1, 2020
1.6 years
June 23, 2020
June 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in depressive symptoms from baseline
Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD)
Week2;Week6
Secondary Outcomes (1)
Changes in anxious symptoms from baseline
week 2; week 6
Study Arms (2)
bright light group
EXPERIMENTALtreat patients with bright light (10000 lux)
dim red light group
PLACEBO COMPARATORtreat patients with dim red light (100 lux)
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
Guanzhou, Guangdong, 510370, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kangguang Lin, MD,PhD
Guangzhou Brain Hospital(Guangzhou Psychiatric Hospital)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Affective Disorder
Study Record Dates
First Submitted
June 23, 2020
First Posted
June 25, 2020
Study Start
June 12, 2020
Primary Completion
December 30, 2021
Study Completion
December 30, 2021
Last Updated
June 25, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share