NCT02769858

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 19, 2017

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

May 10, 2016

Results QC Date

November 22, 2017

Last Update Submit

April 20, 2021

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Light Therapy

EXPERIMENTAL

Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.

Device: Light therapy

Interventions

Light therapyDEVICE

Light therapy glasses

Also known as: Re-Timer
Light Therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Swanson LM, Burgess HJ, Zollars J, Todd Arnedt J. An open-label pilot study of a home wearable light therapy device for postpartum depression. Arch Womens Ment Health. 2018 Oct;21(5):583-586. doi: 10.1007/s00737-018-0836-z. Epub 2018 Mar 30.

    PMID: 29603017DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Dr. Leslie Swanson
Organization
University of Michigan
LMSwan@med.umich.edu
734-239-2248

Study Officials

  • Leslie Swanson, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 12, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 22, 2021

Results First Posted

December 19, 2017

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)