Major DepressionPhase 1NCT00961454
Photobiomodulation to Alter Cerebral Blood Flow and to Affect the Emotional Status of Patients With Major Depression
A Phase 1 study testing Photobiomodulation with a super-luminous light emitting diode in people with Major Depression and Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
A pilot study to evaluate the ability of photobiomodulation to alter cerebral blood flow in the frontal poles and to affect the emotional status of patients with major depression. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depression, Anxiety Disorder, Post-Traumatic Stress Disorder
- What is being tested?
- Photobiomodulation with a super-luminous light emitting diode
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2009
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients must be right handed, between the ages of 18 and 60, and meet criterion for depression on a Structured Clinical Diagnostic Interview
- Enrollment will be made without regard to gender or ethnicity
- Patients who are receiving treatment for depression, either psychological or pharmacological, may continue their treatment during the time of the study, but will be asked to try not to alter their treatment from one month prior to the onset of the experiment until its conclusion. If they must alter their treatment, the patient will continue in the study for observation, but will be excluded from any follow-up statistical comparisons
Who cannot join
- Past history of psychotic disorder (including schizophrenia or schizoaffective disorder
- Bipolar disorder
- Obsessive compulsive disorder)
- Substance abuse disorder that has been active with the past 6 months,
- A history of violent behavior
- A history of a past suicide gesture or attempt
Show all 11Show fewer
- A history of current suicidal ideation
- A history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke)
- Pregnancy
- Current acute or chronic medical condition requiring a medications that has psychological side-effects
- Any person whom we judge to have an impaired decision-making capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Pilot Study to Evaluate the Ability of Photobiomodulation to Alter Cerebral Blood Flow in the Frontal Poles and to Affect the Emotional Status of Patients With Major Depression
A pilot study to evaluate the ability of photobiomodulation to alter cerebral blood flow in the frontal poles and to affect the emotional status of patients with major depression.
Read the detailed description
We wish to study whether photobiomodulation (PBM) with near infrared (NIR) light emitting diodes (LED), a non-ionizing phototherapy, in patients with major depression, can acutely alter frontal brain blood flow measured by near infrared spectroscopy (NIRS).
Secondarily, we will examine whether PBM can improve emotional state immediately and over the following month.
We see this as a pilot study to gather preliminary data that will guide future studies.
- Conditions
- Major Depression, Anxiety Disorder, Post-Traumatic Stress Disorder, Substance Abuse Disorder
- Being tested
- Photobiomodulation with a super-luminous light emitting diode
- Keywords
- Major depressive disorder, anxiety disorders, treatments, photobiomodulation, near infra-red phototherapy, cerebral blood flow
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation with a super-luminous light emitting diodeDevice
Also called Near infra-red light
The treatment will consist of applying PBM in the form of a super-luminous LED with an output of 250 mW/cm2 at a wavelength of 815 nm with a full width half maximum of 40 nm when applied at 4 mm from the skin. The treatment will consist of the exposure to the light for 4 minutes (total delivered fluence per spot of 60 J/cm2) at each of 4 sites on the forehead that correspond to the 10-20 EEG sites, F3, and F4.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Measured: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment
Secondary outcomes (2)
Hamilton Anxiety Rating Scale
Measured: Before treatment, 2-weeks after treatment, and 4-weeks after treatment
Hamilton Anxiety Rating Scale
Measured: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Fredric - Schiffer, M.D., Study director, McLean Hospital and the Harvard Medical SchoolRobert H Webb, Ph.D., Study chair, Massachusetts General HospitalAndrea Johnston, BA, Study chair, Massachusetts General HospitalMartin H Teicher, M.D., Ph.D., Study chair, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961454
- Sponsor's protocol ID
- 2008P-000937
- Status last verified
- Aug 2009
- First submitted
- 18 Aug 2009
- Last updated
- 19 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schiffer F, Johnston AL, Ravichandran C, Polcari A, Teicher MH, Webb RH, Hamblin MR. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behav Brain Funct. 2009 Dec 8;5:46. doi: 10.1186/1744-9081-5-46.
PubMed 19995444
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Ability of Photobiomodulation to Alter Cerebral Blood Flow in the Frontal Poles and to Affect the Emotional Status of Patients With Major Depression
- ClinicalTrials.gov ID
- NCT00961454
- Acronym / sponsor ID
- 2008P-000937
- Conditions
- Major Depression, Anxiety Disorder, Post-Traumatic Stress Disorder, Substance Abuse Disorder
- Keywords
- Major depressive disorder, anxiety disorders, treatments, photobiomodulation, near infra-red phototherapy, cerebral blood flow
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Aug 2009 (estimated)
- 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.
A pilot study to evaluate the ability of photobiomodulation to alter cerebral blood flow in the frontal poles and to affect the emotional status of patients with major depression.
Detailed description
We wish to study whether photobiomodulation (PBM) with near infrared (NIR) light emitting diodes (LED), a non-ionizing phototherapy, in patients with major depression, can acutely alter frontal brain blood flow measured by near infrared spectroscopy (NIRS).
Secondarily, we will examine whether PBM can improve emotional state immediately and over the following month.
We see this as a pilot study to gather preliminary data that will guide future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patients must be right handed, between the ages of 18 and 60, and meet criterion for depression on a Structured Clinical Diagnostic Interview
- Enrollment will be made without regard to gender or ethnicity
- Patients who are receiving treatment for depression, either psychological or pharmacological, may continue their treatment during the time of the study, but will be asked to try not to alter their treatment from one month prior to the onset of the experiment until its conclusion. If they must alter their treatment, the patient will continue in the study for observation, but will be excluded from any follow-up statistical comparisons
Key exclusion criteria (11 listed)
- Past history of psychotic disorder (including schizophrenia or schizoaffective disorder
- Bipolar disorder
- Obsessive compulsive disorder)
- Substance abuse disorder that has been active with the past 6 months,
- A history of violent behavior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation with a super-luminous light emitting diodeAlso: Near infra-red lightThe treatment will consist of applying PBM in the form of a super-luminous LED with an output of 250 mW/cm2 at a wavelength of 815 nm with a full width half maximum of 40 nm when applied at 4 mm from the skin. The treatment will consist of the exposure to the light for 4 minutes (total delivered fluence per spot of 60 J/cm2) at each of 4 sites on the forehead that correspond to the 10-20 EEG sites, F3, and F4. | Device | – |
Primary outcome
Hamilton Depression Rating Scale
Time frame: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment
2 secondary outcomes
Hamilton Anxiety Rating Scale
Time frame: Before treatment, 2-weeks after treatment, and 4-weeks after treatment
Hamilton Anxiety Rating Scale
Time frame: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment.
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 19 Aug 2009.
- Derived from this study: PubMed 19995444Schiffer F, Johnston AL, Ravichandran C, Polcari A, Teicher MH, Webb RH, Hamblin MR. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behav Brain Funct. 2009 Dec 8;5:46. doi: 10.1186/1744-9081-5-46.
Related trials for Major Depression
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Fredric - Schiffer, M.D. study director
McLean Hospital and the Harvard Medical School
Robert H Webb, Ph.D. study chair
Massachusetts General Hospital
Andrea Johnston, BA study chair
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Photobiomodulation with a super-luminous light emitting diode in people with Major Depression and Anxiety Disorder, run by Massachusetts General Hospital 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 3 inclusion and 11 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 19 Aug 2009. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hamilton Depression Rating Scale (time frame: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00961454, which also lists 1 linked publication.
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 19 Aug 2009.