N/A
N=10
The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
Depression, Postpartum
Bottom Line
View on ClinicalTrials.gov: NCT02769858 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks — 24.75; 12.88 SIGH-SAD score — p=.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Light therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks |
24.75; 12.88 | .001 sig |
| PRIMARY Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks |
12.75; 7.75 | .019 sig |
| PRIMARY Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks |
-6 | .502 |
Summary
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).
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02769858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.