N/A
Completed N=49
Transcranial Laser Therapy, Continuous and Pulsed Light, for Major Depressive Disorder (ELATED-3)
Source: ClinicalTrials.gov NCT02959307 ↗Enrolled (actual)
49
Serious AEs
1.6%
Results posted
Sep 2020
Primary outcomePrimary: Quick Inventory of Depressive Symptomatology-Phase 1 — 11.06; 11.24 score on a scale
Summary
Transcranial Light Therapy involves non-invasive and invisible beams of light that increase energy metabolism in the brain. Transcranial light therapy has been found to promote brain metabolism which may help people with depression. The research team proposes a novel approach to treating depression by using transcranial light therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quick Inventory of Depressive Symptomatology-Phase 1 |
11.06; 11.24 | — |
| PRIMARY Quick Inventory of Depressive Symptomatology(QIDS)-Phase 2 |
10.45; 9.14 | — |
| SECONDARY Hamilton Depression Rating Scale - 17 Items(Phase 1) |
16.28; 15.81 | — |
| SECONDARY Hamilton Depression Rating Scale - 17 Items(Phase 2) |
13.50; 14.14 | — |
Eligibility Criteria
Inclusion Criteria
- Participant age at screening will be between (>=)18 and 70 years old (inclusive).
- Participant meets the criteria for major depressive disorder
- Participants informed consent obtained in writing
- Participant is available to participate in the study for at least 12 weeks
Exclusion Criteria
- Significant skin conditions near the application site
- Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment
- Recent history of stroke
- The participant failed more than 2 adequate treatment with Federal Drug Administration approved antidepressants during current episode per antidepressant treatment response questionnaire criteria (less than 50% decrease in depressive symptomatology).
- Structured psychotherapy focused on treating the subject's depression (i.e. cognitive behavioral therapy or interpersonal therapy) is permitted if started at least 8 weeks prior to the screening visit.
- Substance dependence or abuse in the past 3 months.
- History of a psychotic disorder or psychotic episode (current psychotic episode per M.I.N.I neuro-psychiatric assessment).
- Bipolar affective disorder (per M.I.N.I neuro-psychiatric assessment).
- Unstable medical illness, defined as any medical illness which is not well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus, hydrochlorothiazide for hypertension).
- Active suicidal or homicidal ideation (both intention and plan are present), as determined by Columbia Suicide Severity Rating Scale
- Cognitive impairment (Montreal Cognitive Assessment <21)
- The participant 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 in proximity to any of the procedure sites.
- The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised arteriovenous malformation, implantable shunt - Hakim valve).
- Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudyne (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 hydrogen chloride) - for actinic keratosis; 5-aminolevulinic acid for non-melanoma skin cancer)
- Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms plus spermicide) if sexually active.
Data sourced from ClinicalTrials.gov (NCT02959307). 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.