Transcranial Laser Therapy for Major Depressive Disorder

NCT01538199 | Completed Results DMC

• 2 other identifiers: 2010P0027182010A050442
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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)

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

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale (HAM-D 17) Score

  We anticipate that TLT will decrease HAM-D17 scores in study subjects significantly more than Sham treatment. We expect that we will be also able to estimate the effect size of the antidepressant action of TLT. Analyses were done for all evaluable subjects (participants who met the a priori cut-off of a minimum of 4 t-PBM sessions for inclusion in the study analyses) and treatment completers (participants followed for the entire 8-week study period and who received a clinical assessment immediately after). HAM-D17 questions are rated on a scale of 0-4 or 0-2 (total score: 0-50) with higher scores indicating more severe pathology. Scores typically fall into the following ranges: not depressed = 0-7; mildly depressed = 8-13; moderately depressed = 14-18; severely depressed = 19-22; very severely depressed = 23 and over. For the pilot study, we analyzed subjects from Baseline to Week 8. A last observation carried forward (LOCF) was performed to account for one week 8n missing value.

  Visit 1 (Baseline) and Visit 17 (Week 9); Pilot Phase: Visit 1 (Baseline) and Week 8

Secondary Outcomes (2)

• Systematic Assessment for Treatment Emergent Events-systematic Inquiry (SAFTEE-SI)

  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.

• Number of Participants With Adverse Events

  Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17

Study Arms (2)

TLT Treatment Group 1

EXPERIMENTAL

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

TLT Treatment Group 2

SHAM COMPARATOR

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

Device: Sham device

Interventions

Near-infrared radiation via Transcranial LED Therapy 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.

Also known as: PhotoMedex Omnilux New-U, Near-infrared radiation (NIR)

TLT Treatment Group 1

Sham device DEVICE

The sham device does not emit near-infrared radiation.

Also known as: PhotoMedex Omnilux New-U.

TLT Treatment Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Paolo Cassano: lead
• Mclean Hospital: collaborator
• North Suffolk Mental Health Association: collaborator

Study Sites (2)

Massachusetts General Hospital- Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

Chelsea Counseling Center- North Suffolk Mental Health Association

Chelsea, Massachusetts, 02150, United States

Location

Related Publications (1)

• 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.

  PMID: 26356811 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Paolo Cassano
• Organization: Massachusetts General Hospital

pcassano@mgh.harvard.edu

617-643-9622

Study Officials

• Paolo Cassano, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Psychiatrist, Depression Clinical & Research Program (DCRP)

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: February 24, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 29, 2017
• Results First Posted: November 29, 2017

Record last verified: 2017-10

Locations

US (2)