Transcranial Laser Therapy for Major Depressive Disorder (ELATED)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
PhotoThera, Inc
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: April 20, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to see if using Transcranial Laser Therapy (TLT) using the NeuroThera laser System (NTS) 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.

To measure the effect of TLT on the brain, fMRI scans will be performed at three time points during the study at McLean Hospital.

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 brain metabolism of the TLT in depressed subjects (31P-MRS Ancillary Study)

Condition Intervention
Major Depressive Disorder
Device: Near-infrared radiation treatment via TLT (NeuroThera)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Laser Therapeutic Effect in Depression (ELATED): a Placebo-Controlled, Cross-Over Study of Efficacy, Tolerability and Acceptability of a Novel Approach in the Community

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HAM-D 17) [ Time Frame: Screening visit and 12 weeks later (Visit 16) ] [ 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. This will be measured at the Screening Visit and 12 weeks later at Visit 16.


Secondary Outcome Measures:
  • Systematic assessment for treatment emergent events-systematic inquiry (SAFTEE-SI) [ Time Frame: Weeks 2, 3, 4, 5, 6, 7, 8, 9, and 12 ] [ 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: Weeks 2, 3, 4, 5, 6, 7, 8, 9, and 12 ] [ 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: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TLT Treatment Group 1
Subjects in this arm will receive the active TLT treatment in the first three weeks of treatment (weeks 2, 3, and 4) and will crossover at week 5. After week 5, these subjects will receive sham-TLT treatments at weeks 6, 7, and 8.
Device: Near-infrared radiation treatment via TLT (NeuroThera)

The duration of irradiation is 2 minutes at each application site (2 min x 4 sites equivalent to 4 minutes per frontal side), while the entire session is estimated as lasting 20-30 minutes.

Treatment sessions will occur two times per week over three weeks. After the first three weeks there is a crossover period with no TLT treatment. Another treatment wave commences after the crossover period for an additional three weeks at the same frequency. Depending on a subject's treatment group they may receive active TLT in the first treatment wave followed by a sham TLT in the second treatment wave, or vice versus.

Other Names:
  • NeuroThera laser System (NTS)
  • Near-infrared radiation (NIR)
Experimental: TLT Treatment Group 2
Subjects in this arm will receive the sham-TLT treatment in the first three weeks of treatment (weeks 2, 3, and 4) and will crossover at week 5. After week 5, these subjects will receive active TLT treatments at weeks 6, 7, and 8.
Device: Near-infrared radiation treatment via TLT (NeuroThera)

The duration of irradiation is 2 minutes at each application site (2 min x 4 sites equivalent to 4 minutes per frontal side), while the entire session is estimated as lasting 20-30 minutes.

Treatment sessions will occur two times per week over three weeks. After the first three weeks there is a crossover period with no TLT treatment. Another treatment wave commences after the crossover period for an additional three weeks at the same frequency. Depending on a subject's treatment group they may receive active TLT in the first treatment wave followed by a sham TLT in the second treatment wave, or vice versus.

Other Names:
  • NeuroThera laser System (NTS)
  • Near-infrared radiation (NIR)

Detailed Description:

TLT has previously been evaluated in two large studies of people who have had a stroke. A third stroke study is currently ongoing. 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) NTS device is an experimental device. An experimental device means that it is one that has not been approved by the U.S. Food and Drug Administration (FDA). This means that the NTS device can only be used in research studies.

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 is one NTS device that will be used in this study, and this one device produces both active and sham treatment. The NTS device works exactly the same when you are receiving active treatment and sham treatment, except that the device will produce therapeutic transcranial laser energy during the active treatment sessions but it will not produce this laser energy during the sham treatment sessions.

At some time during this study the investigators will use the sham device. At another time, the investigators will use the NIR device. Shams are used in research studies to see if the results are due to the study device or due to other reasons.

The investigators hope to enroll about 30 subjects in this study at North Suffolk Mental Health Association (NSMHA).

The company that makes the NIR NTS device, PhotoThera Inc., is providing the NIR NTS device to us at no cost.

  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)

Additional Exclusion Criteria for the 31P-MRS Ancillary Study:

  • The subject has implanted metal devices, anywhere in the body, which contraindicate 31P-MRS
  • The subject has severe claustrophobia
  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: Charlotte Brill, BA 617-724-2936 cbrill@partners.org
Contact: Paolo Cassano, MD, PhD 617-726-6421 pcassano@partners.org

Locations
United States, Massachusetts
McLean Hospital Not yet recruiting
Belmont, Massachusetts, United States, 02478
Contact: Marc Kaufman, MD    617-855-3469    kaufman@mclean.org   
Principal Investigator: Marc Kaufman, MD         
Massachusetts General Hospital- Depression Clinical and Research Program Recruiting
Boston, Massachusetts, United States, 02114
Contact: Charlotte Brill, BA    617-724-2936    cbrill@partners.org   
Contact: Garret Sacco, BA    617-724-3222    gsacco@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
PhotoThera, Inc
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: April 20, 2012
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:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 22, 2014