Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study

Stopped early · Not applicable

Conditions studied: Generalized Anxiety Disorder

In brief

Transcranial Light Therapy involves non-invasive and invisible beams of light that increase energy metabolism in the brain. Transcranial light therapy has been found to promote brain metabolism which may help people with anxiety. The research team proposes a novel approach to treating anxiety by using transcranial light therapy.

Key facts

Study ID

NCT03420456

Run by

Massachusetts General Hospital

People needed

17

Starts

2018-09-24

Expected to finish

2019-05-06

Last updated by the study team

2020-08-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects age at screening will be between 18 and 70 years old (inclusive).
• Diagnosis of generalized anxiety disorder (MINI) - primary disorder
• CGI-S ≥4 or higher, i.e., "moderately anxious"
• Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms plus spermicide) if sexually active.
• Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
• The subject is willing to participate in this study for at least 16 weeks.
• Subjects will need to be on stable dose(s) of anti-anxiety treatments (if taking any) for at least six weeks prior to enrollment.

You may not qualify if…

• The subject is pregnant or lactating.
• Structured psychotherapy focused on treating the subject's anxiety (i.e. CBT) and other alternative interventions for anxiety are permitted if started at least 8 weeks prior to the screening visit.
• Substance dependence or abuse in the past 3 months.
• History of a psychotic disorder or psychotic episode (current psychotic episode per MINI assessment).
• Bipolar affective disorder (per MINI assessment).
• Unstable medical illness, defined as any medical illness which is not well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus, HCTZ for hypertension).
• Active suicidal or homicidal ideation (both intention and plan are present), as determined by C-SSRS screening.
• Cognitive impairment (MOCA<21)
• 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 in proximity to 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)
• Recent history of stroke (90 days).

Where it is running

• Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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