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Transcranial Laser Therapy for Major Depressive Disorder (ELATED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Massachusetts General Hospital
Sponsor:
Collaborators:
Mclean Hospital
North Suffolk Mental Health Association
Information provided by (Responsible Party):
Paolo Cassano, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01538199
First received: February 17, 2012
Last updated: January 12, 2015
Last verified: January 2015
  Purpose

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)

Condition Intervention
Major Depressive Disorder
Device: Near-infrared radiation via Transcranial LED Therapy
Device: Sham device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HAM-D 17) [ Time Frame: Screening visit and visits 1, 3, 5, 7, 9, 11, 13, 15, and 17 ] [ Designated as safety issue: No ]
    We anticipate that TLT will decrease HAM-D17 (Hamilton Depression rating scale) scores in study subjects significantly more than the Sham treatment. We expect that we will be also able to estimate the effect size of the antidepressant action of TLT.


Secondary Outcome Measures:
  • Systematic assessment for treatment emergent events-systematic inquiry (SAFTEE-SI) [ Time Frame: Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17 ] [ Designated as safety issue: Yes ]

    To assess the safety and tolerability of the TLT in depressed subjects:

    We predict that the TLT will be safe and well-tolerated by depressed patients, as assessed by the following rating scales: SAFTEE-SI. We anticipate no significant differences in between TLT and Sham treatment as concerns side-effects.


  • Adverse Events Form [ Time Frame: Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17 ] [ Designated as safety issue: Yes ]

    To assess the safety and tolerability of the TLT in depressed subjects:

    We predict that the TLT will be safe and well-tolerated by depressed patients, as assessed by the following rating scales: ADVERSE EVENTS FORM. We anticipate no significant differences in between TLT and Sham treatment as concerns side-effects.



Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TLT Treatment Group 1
The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks
Device: 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.

Other Names:
  • PhotoMedex Omnilux New-U
  • Near-infrared radiation (NIR)
Sham Comparator: TLT Treatment Group 2
The sham group will receive 2 treatments of the sham device per week for 8 weeks
Device: Sham device
The sham device does not emit near-infrared radiation.
Other Name: PhotoMedex Omniluc New-U.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 12 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538199

Contacts
Contact: Sam Petrie, BS 617-724-3222 spetrie@mgh.harvard.edu
Contact: Paolo Cassano, MD, PhD 617-643-9622 pcassano@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital- Depression Clinical and Research Program Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sam Petrie, BS    617-724-3222    spetrie@partners.org   
Principal Investigator: Paolo Cassano, MD, PhD         
Chelsea Counseling Center- North Suffolk Mental Health Association Recruiting
Chelsea, Massachusetts, United States, 02150
Contact: Paolo Cassano, MD, PhD    617-889-3300    pcassano@northsuffolk.org   
Principal Investigator: Paolo Cassano, MD, PhD         
Sponsors and Collaborators
Paolo Cassano
Mclean Hospital
North Suffolk Mental Health Association
Investigators
Principal Investigator: Paolo Cassano, MD, PhD Massachusetts General Hospital, Harvard Medical School, and North Suffolk Mental Health Association
  More Information

No publications provided

Responsible Party: Paolo Cassano, Staff Psychiatrist, Depression Clinical & Research Program (DCRP), Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01538199     History of Changes
Other Study ID Numbers: 2010P002718, 2010A050442
Study First Received: February 17, 2012
Last Updated: January 12, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Device study
Depression
Major Depression
Major Depressive Disorder
MDD
Device for depression
Alternatives to medication for depression
Massachusetts General Hospital
Boston

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on February 27, 2015