Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study (Lighten-GAD)
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|ClinicalTrials.gov Identifier: NCT03420456|
Recruitment Status : Terminated (Sponsor withdrew funding for reasons unrelated to safety or efficacy)
First Posted : February 5, 2018
Last Update Posted : August 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder||Device: Transcranial Light Therapy||Not Applicable|
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 randomized at a 1:2 ratio into 2 groups: pulse light (TLT) and sham. The sham group will be randomized after 8 weeks at a 1:1 ratio in to TLT and sham.
The study involves 1 screening visit which may last up to 3 hours, 16 weekly study visits, and one follow-up visit. There are 2 in-office treatment visits, during which a clinician applies transcranial light therapy to the participant's head for about 30 minutes. The other study visits involve assessments with a study clinician. The participants will administer the treatment once daily at home during the 16-week treatment period.
If a participant qualifies for the study, the study team assigns the participant by chance to receive either active transcranial light therapy or sham transcranial light therapy treatment. During sham transcranial light therapy visits, the transcranial light therapy device will not produce near infrared waves (e.g., light energy that cannot penetrate the skin and cranium). Participants have more than an equal chance of being assigned to the active transcranial light therapy or the sham transcranial light therapy over the course of the study. Neither the participant, nor the clinician, nor any research staff other than the study statistician will know which study group the participant belongs.
Participants are randomized a second time after 8-weeks in the study. If the participant were in the sham group the first 8-weeks, that participant may receive the active transcranial light therapy treatment after re-randomization. If the participant were already in the active transcranial light therapy group during the first 8-weeks the participant continues receiving the active treatment. All in all, participants have a 2 in 3 chance of receiving the active transcranial light therapy treatment at some point during the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pilot study|
|Masking:||None (Open Label)|
|Masking Description:||This is an open label pilot study|
|Official Title:||Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study (Lighten-GAD)|
|Actual Study Start Date :||September 24, 2018|
|Actual Primary Completion Date :||May 6, 2019|
|Actual Study Completion Date :||May 6, 2019|
Experimental: Transcranial Light Therapy
Transcranial light therapy penetrates the skin and brain using light energy and the light energy may activate under-stimulated brain regions.
Device: Transcranial Light Therapy
Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
- Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) [ Time Frame: 8 weeks - Sequential-parallel comparison design ]This instrument is completed by the clinician based on his/her assessment of the patient's anxiety symptoms, using a structured interview, specific instructions, and defined anchor points. Answers to the questions are rated on a scale of 0-4, with higher scores indicating more severe pathology. Scores range between 0 to 56; <17 indicates mild severity, 18-24 mild-to-moderate severity, and 25-30 moderate to severe.
- Clinical Global Impressions - Severity and Improvement (CGI-S, CGI-I) [ Time Frame: 8 weeks - Sequential-parallel comparison design ]These two instruments are scored 1-7 by the clinician based on assessment of the subject's overall clinical status. They measure, based on history and scores on other instruments: (a) symptom severity (CGI-S) and (b) clinical improvement (CGI-I).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420456
|United States, Massachusetts|
|Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Paolo Cassano, MD||Center for Anxiety and Traumatic Stress Disorders|