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

Primary Purpose

Major Depression, Anxiety Disorder, Post-Traumatic Stress Disorder

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Photobiomodulation with a super-luminous light emitting diode

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Major depressive disorder, anxiety disorders, treatments, photobiomodulation, near infra-red phototherapy, cerebral blood flow

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wellman Center for Photomedicine, Massachusetts General Hospital

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale

Secondary Outcome Measures

Hamilton Anxiety Rating Scale

Full Information

NCT ID

NCT00961454

First Posted

August 18, 2009

Last Updated

August 18, 2009

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00961454

Brief Title

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

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Photobiomodulation with a super-luminous light emitting diode

Other Intervention Name(s)

Near infra-red light

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hamilton Depression Rating Scale

Time Frame

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

Secondary Outcome Measure Information:

Title

Hamilton Anxiety Rating Scale

Time Frame

Before treatment, 2-weeks after treatment, and 4-weeks after treatment

Title

Hamilton Anxiety Rating Scale

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fredric - Schiffer, M.D.

Organizational Affiliation

McLean Hospital and the Harvard Medical School

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Robert H Webb, Ph.D.

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Andrea Johnston, BA

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Martin H Teicher, M.D., Ph.D.

Organizational Affiliation

Mclean Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Wellman Center for Photomedicine, Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19995444

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.

Results Reference

derived

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

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