Major Depressive Disorder Clinical Trial
— ELATEDOfficial 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
Verified date | October 2017 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 28 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital- Depression Clinical and Research Program | Boston | Massachusetts |
United States | Chelsea Counseling Center- North Suffolk Mental Health Association | Chelsea | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Paolo Cassano | Mclean Hospital, North Suffolk Mental Health Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Systematic Assessment for Treatment Emergent Events-systematic Inquiry (SAFTEE-SI) | To assess the safety and tolerability of TLT in depressed subjects: We predict that TLT will be safe and well-tolerated, as assessed by the SAFTEE-SI. We anticipate no significant differences between TLT and Sham in side-effects.The SAFTEE is a commonly used instrument developed by the NIMH and adapted into a self-report instrument. The version we used is the same used by the NIMH-sponsored CO-MED trial. It examines all possible treatment-emergent side effects and adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior. The SAFTEE analyses are ongoing and will be reported in a second paper (they are not included in the primary outcomes paper). The single value analyzed is the total number of distinct treatment-emergent side-effects (a side effect is defined as any item on the SAFTEE for which severity increased by two or more levels from baseline to any visit) that occurred for each subject. Range: 0 to 165; higher values represent worse outcomes. |
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. | |
Secondary | Number of Participants With Adverse Events | 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. Due to the small sample size and the variability of reported adverse events, we decided that descriptive reporting (i.e. reporting each subject's adverse events individually) was more appropriate than analysis. All adverse events were reported in the adverse events section. In the outcome measure data table below we report the number of participants in each group who experienced an adverse event. |
Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17 |
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