Transcranial Laser Therapy for Major Depressive Disorder

Completed · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study is to see if using Transcranial LED Therapy (TLT) using the PhotoMedex's Omnilux NEw-U LED helps improve symptoms of major depressive disorder (MDD). TLT works by briefly delivering near-infrared (non-visible) radiations to the forehead. The radiations penetrate the brain and stimulate the cells \& metabolism. Our goals are * To assess the antidepressant effect of the TLT in depressed subjects. * To assess the safety and tolerability of the TLT in depressed subjects * To assess the acceptability of the TLT in depressed subjects * To pilot test the impact on cognition of the TLT in depressed subjects (Ancillary Study)

Key facts

Study ID

NCT01538199

Run by

Paolo Cassano

People needed

28

Starts

2012-02-01

Expected to finish

2015-08-01

Last updated by the study team

2017-11-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is at least 18 years of age at screening, but has not had their 66th birthday.
• SCID diagnosis of major depressive disorder (Structured Clinical Interview for Diagnostic Statistical Manual-IV)
• HAM-D-17 >14 and < 25
• Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms with spermicide) if sexually active.
• Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
• The subject (and caregiver, if applicable) is willing to participate in this study for at least 8 weeks.
• Subjects on an antidepressant will need to be on a stable dose for at least six weeks.

You may not qualify if…

• The subject is pregnant or lactating.
• The subject failed two or more FDA-approved antidepressants during current episode
• Subjects with less than 2 months MDD symptom free prior to current episode.
• The subject used targeted psychotherapies for depression during current episode (support therapy or counseling are allowed)
• Substance dependence or abuse in the past 6 months
• Psychotic disorder or psychotic episode (current psychotic episode per SCID assessment)
• Bipolar affective disorder (per SCID assessment)
• Unstable medical illness, defined as any medical illness which has not been well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus, HCTZ for hypertension)
• Active suicidal or homicidal ideation, as determined by CHRT screening
• The subject has a significant skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on the subject's scalp that is found to be directly below any of the procedure sites.
• The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve).
• Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer)

Where it is running

• Massachusetts General Hospital- Depression Clinical and Research Program — Boston, Massachusetts, United States
• Chelsea Counseling Center- North Suffolk Mental Health Association — Chelsea, Massachusetts, United States

Full record on ClinicalTrials.gov

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