Clinical trial NCT01538199: Transcranial Laser Therapy for Major Depressive Disorder
Official title: Evaluation of LED Therapeutic Effect in Depression (ELATED): a Placebo-Controlled, Parallel Study of Efficacy, Tolerability and Acceptability of a Novel Approach in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mclean Hospital
name: North Suffolk Mental Health Association
First posted: 2012-02-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale (HAM-D 17) Score
timeFrame: Visit 1 (Baseline) and Visit 17 (Week 9); Pilot Phase: Visit 1 (Baseline) and Week 8
Secondary outcomes:
measure: Systematic Assessment for Treatment Emergent Events-systematic Inquiry (SAFTEE-SI)
timeFrame: Assessed at odd-numbered Visits 1-17. The single value to be analyzed is the number of distinct side effects that occurred at least once during these assessment visits for each subject.
measure: Number of Participants With Adverse Events
timeFrame: Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital- Depression Clinical and Research Program
state: Massachusetts
city: Chelsea
country: United States
facility: Chelsea Counseling Center- North Suffolk Mental Health Association
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital, Harvard Medical School, and North Suffolk Mental Health Association
name: Paolo Cassano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.