Clinical trial NCT00961454: Photobiomodulation to Alter Cerebral Blood Flow and to Affect the Emotional Status of Patients With Major Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment
Secondary outcomes:
measure: Hamilton Anxiety Rating Scale
timeFrame: Before treatment, 2-weeks after treatment, and 4-weeks after treatment
measure: Hamilton Anxiety Rating Scale
timeFrame: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Wellman Center for Photomedicine, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: McLean Hospital and the Harvard Medical School
name: Fredric - Schiffer, M.D.
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Robert H Webb, Ph.D.
role: STUDY_CHAIR
affiliation: Massachusetts General Hospital
name: Andrea Johnston, BA
role: STUDY_CHAIR
affiliation: Mclean Hospital
name: Martin H Teicher, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: 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.