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Clinical Trials/NCT00961454
NCT00961454CompletedPhase 1

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

Massachusetts General Hospital2 sites in 1 country10 target enrollmentStarted: January 1, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
10
Locations
2
Primary Endpoint
Hamilton Depression Rating Scale
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale

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

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (2)

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