Photobiomodulation to Alter Cerebral Blood Flow 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

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 Overview

• Status: Completed
• Conditions: Major Depression; Post-Traumatic Stress Disorder; Anxiety Disorder; Substance Abuse Disorder
• Intervention / Treatment: Device: Photobiomodulation with a super-luminous light emitting diode

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Wellman Center for Photomedicine, Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hamilton Depression Rating Scale	Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Hamilton Anxiety Rating Scale	Before treatment, 2-weeks after treatment, and 4-weeks after treatment
Hamilton Anxiety Rating Scale	Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Study Director: Fredric - Schiffer, M.D., McLean Hospital and the Harvard Medical School; Study Chair: Robert H Webb, Ph.D., Massachusetts General Hospital; Study Chair: Andrea Johnston, BA, Massachusetts General Hospital; Study Chair: Martin H Teicher, M.D., Ph.D., Mclean Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: August 18, 2009
• First Submitted That Met QC Criteria: August 18, 2009
• First Posted (Estimate): August 19, 2009

Study Record Updates

• Last Update Posted (Estimate): August 19, 2009
• Last Update Submitted That Met QC Criteria: August 18, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Major depressive disorder, anxiety disorders, treatments, photobiomodulation, near infra-red phototherapy, cerebral blood flow
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Mood Disorders; Trauma and Stressor Related Disorders; Substance-Related Disorders; Depression; Depressive Disorder; Disease; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Depressive Disorder, Major
• Other Study ID Numbers: 2008P-000937