- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04385394
Bright Light Therapy as Augmentation of Depressive Symptoms on Acute Psychiatric Floor (BLT)
Bright Light Therapy as Augmentation of Depressive Symptoms as Measured by Changes in Beck Depression Inventory, Hamilton Rating Scale for Depression and Outcome Questionnaire-45 on Acute Psychiatric Floor
Study Overview
Status
Conditions
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
- Melanopsin (Intrinsic Photo receptor ganglion Cells)
- Suprachiasmatic Nucleus (SCN, master clock) which follows a rhythmic change
- 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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- 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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
depression scores
Time Frame: 7 days
|
changes in depression scores, administered before light therapy and prior to discharge (corresponds to the last session of light therapy)
|
7 days
|
|
Functioning scores
Time Frame: 7 days
|
symptoms distress, interpersonal functioning, social role
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
length of stay
Time Frame: 7 days
|
duration of stay on an inpatient unit in days
|
7 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Luba Leontieva, MD, PhD, State University of New York - Upstate Medical University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1507582-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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