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

Depression, Postpartum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769858
• Other study ID #: G016030
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

Device:
• Light therapy
Light therapy glasses

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks	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	After five weeks of light therapy
Primary	Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks	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.	After five weeks of light therapy
Primary	Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks	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	After five weeks of light therapy