The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression

The proposed study aims to establish the feasibility of light therapy for postpartum depression delivered via Re-Timer, demonstrate its preliminary efficacy, and illuminate relationships between circadian shifts and mood changes using a novel, home-based circadian biomarker assessment paradigm (salivary dim light melatonin onset; DLMO).

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Key information

Conditions

Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Within 6 months postpartum
Meet DSM-V diagnostic criteria for MDD
Score ≥ 20 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder version (SIGH-SAD).

Exclusion criteria

current diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V
past history of mania/hypomania,
chronic medical conditions associated with depression (e.g., thyroid conditions)
ocular or retinal pathology
history of seizures or epilepsy
color blindness
Lupus
currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (Accutane).

Treatment and study plan

Light Therapy

Device

Light therapy glasses

Other names: Re-Timer

Primary outcomes

Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks

Time frame: After five weeks of light therapy

Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) (29 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 -73, where 0 means no depression, and 73 is the greatest possible depression. Generally scores of 20 or higher represent clinical depression
Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks

Time frame: After five weeks of light therapy

Self-report of depression symptoms. The Edinburgh Postnatal Depression scale is scored from 0 to 30 where 0 is no depression and 30 is most severe depression.
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks

Time frame: After five weeks of light therapy

Onset of melatonin in dim light conditions as measured in saliva (also called DLMO) Time of DLMO is measured in clock time, so a positive number in change would represent a later onset of melatonin and a negative number represents an earlier onset of melatonin

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: May 12, 2016
Registry last updated: Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed