CClinicalTrials.gg
CompletedNCT04385394BLTUpdated Oct 28, 2021

Bright Light Therapy as Augmentation of Depressive Symptoms on Acute Psychiatric Floor

An observational study in Depression, sponsored by State University of New York - Upstate Medical University. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by State University of New York - Upstate Medical University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The purpose of this study is to explore if Bright Light Therapy (BLT) as augmentation of depression treatment on an acute psychiatric floor is feasible, helps alleviate depressive symptoms, improve functioning, and decrease length of stay on the psychiatric floor.

Read the detailed description

Background:

Bright light therapy is an evidence-based treatment for seasonal depression (SAD), recently there is evidence that it has some efficacy in nonseasonal major depressive disorder (MDD) when used together with antidepressants.

BLT works via the patient's eyes through

  1. Melanopsin (Intrinsic Photo receptor ganglion Cells)
  2. Suprachiasmatic Nucleus (SCN, master clock) which follows a rhythmic change
  3. Serotonin

A number of studies showed seasonal changes in serotonergic parameters, including brain serotonin concentration and turnover. There were no research on using the BLT on the acute inpatient floor to augment the antidepressant treatment. Yet, there is a great need for such augmentation as for Selective Serotonin Reuptake Inhibitors (SSRI) to take full effect 4-6 weeks needed. Moreover, patients with depression often do not spend enough time on the direct sun light, which exacerbate and prolong their depressed mood. The augmentation with the BLT on the acute psychiatric floor will help the antidepressant work, expedite the recovery, and potentially shortens the length of stay in the hospital, which in turn will lead to an economic saving and faster return of the patient into the community and to the workforce.

Method:

This is an observational, case series study. All patients that meet exclusion criteria will have equal chance to receive BLT. We will administer the questionnaires before the BLT and at the end of treatment. Patient will continue to receive the pharmacological and therapeutic treatment on psychiatric floor as usual during the BLT. We will evaluate the changes in the questionnaires before and after BLT treatment, the length of stay on the unit. We will analyze the contributing factors such as age, gender, duration of depressive symptoms, other psychiatric and medical comorbidities, social factors (homelessness, social support, etc), current psychiatric medications.

Eligible patients will be invited to participate and consent will be obtain.

  • The type of light we use is the "Sun Box Sun Square +"
  • Emits about 10,000 lux of light and is wide enough to be used for more than 2 people.
  • 186 watts
  • Full spectrum 5000k white light (without the UV)
  • It has an inbuilt spectrally transparent prismatic diffuser that blocks UV, that does not filter the quality of light and will not yellow.
  • Minimal heat and no bulb flutter.
  • Where: Bedroom / Common sitting area
  • Reading/ Having breakfast/ Watching tv/Drawing
  • Just after awakening within an hour early morning
  • 30 mins/day
  • Must have eyes open, but not looking into the light
  • Staff will monitor while the patients are under the BLT
02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 100 is below the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

State University of New York - Upstate Medical University is the lead sponsor of 154 studies on the registry; 17 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

inpatients reporting depressive symptoms that meet inclusion criteria

Inclusion criteria

  • depressive symptoms on BDI (score 14 and above - eligible for BLT) and/or
  • depressive symptoms on HAMD-17 (score 8 and above)

Exclusion criteria

Exclusion Criteria:

  • no report of depressive symptoms; manic symptoms, acute psychosis, schizophrenia, schizoaffective disorder, impending Electro Convulsive Therapy (ECT), retinal risk factors, lupus, bright light sensitivity, glaucoma, cataracts, retinal detachment, retinopathy, patients on photosensitizing meds (tetracycline, sulfonamides, psoralens, and phenothiazine antipsychotics)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. depression scores

    changes in depression scores, administered before light therapy and prior to discharge (corresponds to the last session of light therapy)

    Time frame: 7 days

  2. Functioning scores

    symptoms distress, interpersonal functioning, social role

    Time frame: 7 days

Secondary outcomes

  1. length of stay

    duration of stay on an inpatient unit in days

    Time frame: 7 days

07

Study locations

1 site
  • SUNY Upstate Medical University
    Syracuse, New York 13210, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04385394
Lead sponsor
State University of New York - Upstate Medical University
Responsible party
Sponsor
First posted
May 12, 2020
Start date
Jan 30, 2020
Primary completion
Aug 20, 2020
Completion
Aug 20, 2020
Last update
Oct 28, 2021

Study contacts

Luba Leontieva, MD, PhD
principal investigator · State University of New York - Upstate Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion