Status:
TERMINATED
Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
NYU Langone Health
Cerebral Sciences LLC
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The purpose of this study is to see if using Transcranial Light Therapy (TLT), also called near- infrared light, helps improve symptoms of generalized anxiety disorder (GAD). Subjects will be randomiz...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
September 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03420456
Start Date
September 24 2018
End Date
May 6 2019
Last Update
August 5 2020
Active Locations (1)
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1
Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders
Boston, Massachusetts, United States, 02114