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

Phase 1

Completed

• Conditions: Major Depression; Anxiety Disorder; Post-Traumatic Stress Disorder; Substance Abuse Disorder

• Registration Number: NCT00961454
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-08
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-18
• Last Update Submitted: 2009-08-18
• Study First Posted: 2009-08-19
• Last Update Posted: 2009-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment

Secondary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale	Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment.

Trial Locations

Locations (1)

Wellman Center for Photomedicine, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States