Photobiomodulation to Alter Cerebral Blood Flow and to Affect the Emotional Status of Patients With Major Depression

NCT00961454 | Completed Phase 1 DMC

• 1 other identifier: 2008P-000937
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale

  Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment

Secondary Outcomes (2)

• 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.

Interventions

Photobiomodulation with a super-luminous light emitting diode DEVICE

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.

Also known as: Near infra-red light

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Wellman Center for Photomedicine, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 19995444 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders; Stress Disorders, Post-Traumatic; Substance-Related Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Fredric - Schiffer, M.D.

  McLean Hospital and the Harvard Medical School

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 19, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 19, 2009

Record last verified: 2009-08

Locations

US (1)