Transcranial Laser Therapy for Major Depressive Disorder

NCT ID: NCT01538199

Last Updated: 2017-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-08-31

Brief Summary

The purpose of this study is to see if using Transcranial LED Therapy (TLT) using the PhotoMedex's Omnilux NEw-U LED helps improve symptoms of major depressive disorder (MDD). TLT works by briefly delivering near-infrared (non-visible) radiations to the forehead. The radiations penetrate the brain and stimulate the cells & metabolism.

Our goals are

• To assess the antidepressant effect of the TLT in depressed subjects.
• To assess the safety and tolerability of the TLT in depressed subjects
• To assess the acceptability of the TLT in depressed subjects
• To pilot test the impact on cognition of the TLT in depressed subjects (Ancillary Study)

Detailed Description

TLT has previously been evaluated in two large studies of people who have had a stroke. To date, TLT has been administered to over 550 people who have had a stroke. TLT has also been used in 10 people with MDD who were taking part in a research study. During this study, TLT was shown to relieve MDD symptoms without causing too many side effects.

The -Infrared Radiation (NIR) device is also marketed for wrinkles treatment, however it is experimental for the use in depression. An experimental device means that it is one that has not been approved by the U.S. Food and Drug Administration (FDA).

During this study, the investigators hope to better find out if NIR TLT is helpful for treating depression. The investigators will do this by comparing the effects of TLT ("active treatment") NIR device to a sham treatment (which is an inactive or "pretend" treatment) device. The sham ("pretend") device looks exactly like the NIR device but will not use a near-infrared radiation during the study visits. There are two sets of identical devices that will be used in this study, producing active and sham treatment, respectively. The devices work exactly the same when you are receiving active treatment and sham treatment, except that the devices will produce therapeutic transcranial LED energy during the active treatment sessions but it will not produce this LED energy during the sham treatment sessions.

The investigators hope to enroll about 30 subjects in this study at the Massachusetts General Hospital Depression Clinical and Research Program.

Conditions

Major Depressive Disorder

Keywords

Device study; Depression; Major Depression; Major Depressive Disorder; MDD; Device for depression; Alternatives to medication for depression; Massachusetts General Hospital; Boston

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TLT Treatment Group 1

The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks

Group Type: EXPERIMENTAL

Near-infrared radiation via Transcranial LED Therapy

Intervention Type: DEVICE

The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.

The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject.

TLT Treatment Group 2

The sham group will receive 2 treatments of the sham device per week for 8 weeks

Group Type: SHAM_COMPARATOR

Sham device

Intervention Type: DEVICE

The sham device does not emit near-infrared radiation.

Interventions

Near-infrared radiation via Transcranial LED Therapy

The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.

The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject.

Intervention Type: DEVICE

Sham device

The sham device does not emit near-infrared radiation.

Intervention Type: DEVICE

Other Intervention Names

PhotoMedex Omnilux New-U; Near-infrared radiation (NIR); PhotoMedex Omnilux New-U.

Eligibility Criteria

Inclusion Criteria

• The subject is at least 18 years of age at screening, but has not had their 66th birthday.
• SCID diagnosis of major depressive disorder (Structured Clinical Interview for Diagnostic Statistical Manual-IV)
• HAM-D-17 >14 and < 25
• Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms with spermicide) if sexually active.
• Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
• The subject (and caregiver, if applicable) is willing to participate in this study for at least 8 weeks.
• Subjects on an antidepressant will need to be on a stable dose for at least six weeks.

Exclusion Criteria

• The subject is pregnant or lactating.
• The subject failed two or more FDA-approved antidepressants during current episode
• Subjects with less than 2 months MDD symptom free prior to current episode.
• The subject used targeted psychotherapies for depression during current episode (support therapy or counseling are allowed)
• Substance dependence or abuse in the past 6 months
• Psychotic disorder or psychotic episode (current psychotic episode per SCID assessment)
• Bipolar affective disorder (per SCID assessment)
• Unstable medical illness, defined as any medical illness which has not been well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus, HCTZ for hypertension)
• Active suicidal or homicidal ideation, as determined by CHRT screening
• 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 directly below 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mclean Hospital

OTHER

Sponsor Role: collaborator

North Suffolk Mental Health Association

OTHER

Sponsor Role: collaborator

Paolo Cassano

OTHER

Sponsor Role: lead

Responsible Party

Paolo Cassano

Staff Psychiatrist, Depression Clinical & Research Program (DCRP)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paolo Cassano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital, Harvard Medical School, and North Suffolk Mental Health Association

Locations

Massachusetts General Hospital- Depression Clinical and Research Program

Boston, Massachusetts, United States

Chelsea Counseling Center- North Suffolk Mental Health Association

Chelsea, Massachusetts, United States

Countries

United States

References

Cassano P, Cusin C, Mischoulon D, Hamblin MR, De Taboada L, Pisoni A, Chang T, Yeung A, Ionescu DF, Petrie SR, Nierenberg AA, Fava M, Iosifescu DV. Near-Infrared Transcranial Radiation for Major Depressive Disorder: Proof of Concept Study. Psychiatry J. 2015;2015:352979. doi: 10.1155/2015/352979. Epub 2015 Aug 19.

Reference Type: DERIVED

PMID: 26356811 (View on PubMed)

Other Identifiers

2010A050442

Identifier Type: OTHER

Identifier Source: secondary_id

2010P002718

Identifier Type: -

Identifier Source: org_study_id