Post-Traumatic Stress Disorder Clinical Trial
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
Verified date | August 2009 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Wellman Center for Photomedicine, Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Rating Scale | Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment | Yes | |
Secondary | Hamilton Anxiety Rating Scale | Before treatment, 2-weeks after treatment, and 4-weeks after treatment | Yes | |
Secondary | Hamilton Anxiety Rating Scale | Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment. | Yes |
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