DepressionBLTNCT04385394
Bright Light Therapy as Augmentation of Depressive Symptoms on Acute Psychiatric Floor
An observational study of Depression, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Depression
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 20 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: inpatients reporting depressive symptoms that meet inclusion criteria
Who may be able to join
- depressive symptoms on BDI (score 14 and above - eligible for BLT) and/or
- depressive symptoms on HAMD-17 (score 8 and above)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: 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
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
- 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
- Conditions
- Depression
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
depression scores
changes in depression scores, administered before light therapy and prior to discharge (corresponds to the last session of light therapy)
Measured: 7 days
Functioning scores
symptoms distress, interpersonal functioning, social role
Measured: 7 days
Secondary outcomes (1)
length of stay
duration of stay on an inpatient unit in days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start30 Jan 2020
- Primary completion20 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luba Leontieva, MD, PhD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385394
- Sponsor's protocol ID
- 1507582-1
- Acronym
- BLT
- Status last verified
- Oct 2021
- First submitted
- 23 Dec 2019
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04385394
- Acronym / sponsor ID
- BLT / 1507582-1
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- inpatients reporting depressive symptoms that meet inclusion criteria
Key inclusion criteria (2 listed)
- depressive symptoms on BDI (score 14 and above - eligible for BLT) and/or
- depressive symptoms on HAMD-17 (score 8 and above)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Functioning scores
Time frame: 7 days
symptoms distress, interpersonal functioning, social role
1 secondary outcome
length of stay
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luba Leontieva, MD, PhD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depression scores (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.