Generalized Anxiety DisorderLighten-GADNCT03420456
Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study
A study testing Transcranial Light Therapy in people with Generalized Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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 may help people with anxiety. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Transcranial Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 6 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders
Boston, Massachusetts, 02114
About this study
Official title: Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study (Lighten-GAD)
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.
Read the 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 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Transcranial Light Therapy
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Light TherapyDevice
Also called Low Level Laser-Light Therapy, Photobiomodulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Light Therapy | Experimental | Transcranial light therapy penetrates the skin and brain using light energy and the light energy may activate under-stimulated brain regions. Receives: Device: Transcranial Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A)
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.
Measured: 8 weeks - Sequential-parallel comparison design
Secondary outcomes (1)
Clinical Global Impressions - Severity and Improvement (CGI-S, CGI-I)
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).
Measured: 8 weeks - Sequential-parallel comparison design
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start24 Sep 2018
- Primary completion6 May 2019
- Study completion6 May 2019
Why it stopped: Sponsor withdrew funding for reasons unrelated to safety or efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health, Cerebral Sciences LLC
- Responsible party
- Principal investigator, Paolo Cassano, Massachusetts General Hospital
- Investigators
- Paolo Cassano, MD, Principal investigator, Center for Anxiety and Traumatic Stress Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420456
- Sponsor's protocol ID
- 2017P002231
- Acronym
- Lighten-GAD
- Status last verified
- Aug 2020
- First submitted
- 29 Jan 2018
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Personally unidentifiable information will be sent to Dr. Anastasia Ivanova, a privately contracted biostatistician form Chapel Hill North Carolina, for consultation on analyses. All information sent to Dr. Ivanova uses acrostics in place of personally identifiable information.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study (Lighten-GAD)
- ClinicalTrials.gov ID
- NCT03420456
- Acronym / sponsor ID
- Lighten-GAD / 2017P002231
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew funding for reasons unrelated to safety or efficacy
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- NYU Langone Health, Cerebral Sciences LLC
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Transcranial Light Therapy | Experimental | Device: Transcranial Light TherapyTranscranial light therapy penetrates the skin and brain using light energy and the light energy may activate under-stimulated brain regions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Light TherapyAlso: Low Level Laser-Light Therapy, PhotobiomodulationTranscranial 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. | Device | Transcranial Light Therapy |
Primary outcome
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.
1 secondary outcome
Clinical Global Impressions - Severity and Improvement (CGI-S, CGI-I)
Time frame: 8 weeks - Sequential-parallel comparison design
Results and safety
The study was stopped early (reason given: Sponsor withdrew funding for reasons unrelated to safety or efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: Yes. Personally unidentifiable information will be sent to Dr. Anastasia Ivanova, a privately contracted biostatistician form Chapel Hill North Carolina, for consultation on analyses. All information sent to Dr. Ivanova uses acrostics in place of personally identifiable information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Cassano, MD principal investigator
Center for Anxiety and Traumatic Stress Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Light Therapy in people with Generalized Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor withdrew funding for reasons unrelated to safety or efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) (time frame: 8 weeks - Sequential-parallel comparison design). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.