N/A
Completed N=28
Transcranial Laser Therapy for Major Depressive Disorder
Source: ClinicalTrials.gov NCT01538199 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Change in Hamilton Depression Rating Scale (HAM-D 17) Score — -11.7; -5.3; -15.7; -6.1 units on a scale — p=0.04
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Depression Rating Scale (HAM-D 17) Score |
-11.7; -5.3; -15.7; -6.1; -6.75 | 0.04 sig |
| SECONDARY Systematic Assessment for Treatment Emergent Events-systematic Inquiry (SAFTEE-SI) |
-17; -9.38; -10.33 | — |
| SECONDARY Number of Participants With Adverse Events |
7; 2; 1; 1 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01538199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.