Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT03420456
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03420456
Study Brief:
Protocol Section:
NCT03420456