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Trial record 98 of 1053 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

Transcranial Laser Therapy for Major Depressive Disorder (ELATED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01538199
Recruitment Status : Completed
First Posted : February 24, 2012
Results First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Collaborators:
Mclean Hospital
North Suffolk Mental Health Association
Information provided by (Responsible Party):
Paolo Cassano, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Device: Near-infrared radiation via Transcranial LED Therapy
Device: Sham device
Enrollment 28
Recruitment Details Participants were recruited in 2012 for the pilot phase of the study. Participants were recruited from February 2014 through June 2015 via Craigslist advertisements and the general research phone line for the Depression Clinical and Research Program at Massachusetts General Hospital.
Pre-assignment Details 10 subjects from the pilot phase and 9 subjects from phase 2 screen failed (HAM-D scores below or above threshold, active substance abuse, exclusionary comorbid medical disorder, did not pass drug screen, just started psychotherapy). 6 participants dropped out after screen (time constraints, moving, LTFU). 1 subject had primary diagnosis of PTSD.
Arm/Group Title TLT Treatment Group 1 (Active TLT Treatment) TLT Treatment Group 2 (Placebo) Pilot Study Treatment Group 1 Pilot Study Treatment Group 2
Hide Arm/Group Description

The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks

Near-infrared radiation via Transcranial LED Therapy: 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.

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

Sham device: The sham device does not emit near-infrared radiation.

The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.

(see protocol change 10/28/2014)

The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.

(see protocol change 10/28/2014)

Period Title: Overall Study
Started 10 11 4 3
Completed [1] 8 [2] 8 [2] 3 [3] 1 [4]
Not Completed 2 3 1 2
Reason Not Completed
Lost to Follow-up             1             2             1             0
participant did not have time             1             0             0             2
Lack of Efficacy             0             1             0             0
[1]
1 active participant excluded as "completer" in analyses because last visit was out of window.
[2]
1 completed study but was excluded as a "completer" from analyses because started a new treatment
[3]
1 non-completer included in analyses because only missed follow up, completed all treatment visits.
[4]
Completer excluded from analyses because determined to be not eligible at end of study.
Arm/Group Title TLT Treatment Group 1 TLT Treatment Group 2 Screen Fail/Not Randomized Pilot Study Treatment Group 1 Pilot Study Treatment Group 2 Pilot Study Screen Fail/Not Randomized Total
Hide Arm/Group Description

The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks

Near-infrared radiation via Transcranial LED Therapy: 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.

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

Sham device: The sham device does not emit near-infrared radiation.

9 participants screen failed (3 had HAM-D scores that were below the threshold for study inclusion, 2 had bipolar disorder, 1 had active substance abuse, 1 had an exclusionary comorbid medical disorder, 1 did not pass drug screen, 1 was not depressed) . 5 participants decided not to participate after the screen (1 due to time commitment, 2 were no longer interested, 1 was moving away, and 1 was lost to follow up). 1 was discontinued by investigator pre randomization at Visit 1 because it was discovered at Visit 1 that the patient's primary diagnosis was PTSD (MDD was secondary). Additionally, the patient's trauma symptoms significantly interfered with their ability to complete the study tasks.

The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.

(see protocol change 10/28/2014)

The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.

(see protocol change 10/28/2014)

10 participants screen failed (5 had HAM-D scores that were above threshold for study inclusion criteria, 1 had too many failed trials in the current depressive episode, 1 had active substance abuse, 2 did not meet criteria for Major Depressive Disorder at the time of the screening visit, 1 had just started psychotherapy at the time of the screen). 1 participant dropped out pre-randomization due to time constraints.

(see protocol change 10/28/2014)

Total of all reporting groups
Overall Number of Baseline Participants 10 11 15 4 3 11 54
Hide Baseline Analysis Population Description
TLT: 3 randomized participants completed less than 4 treatments so they were not included in analyses. 9 participants screen failed. 5 participants decided not to participate after the screen (time commitment, no longer interested, etc). 1 participant was discontinued by the investigator pre-treatment - discovered that primary diagnosis was PTSD.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 15 participants 4 participants 3 participants 11 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
11
 100.0%
15
 100.0%
4
 100.0%
3
 100.0%
11
 100.0%
54
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 15 participants 4 participants 3 participants 11 participants 54 participants
45  (12.8) 50.7  (13.3) 49.9  (10.8) 47  (14) 47.7  (13.5) 38.3  (11.7) 46.4  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 15 participants 4 participants 3 participants 11 participants 54 participants
Female
6
  60.0%
7
  63.6%
8
  53.3%
1
  25.0%
3
 100.0%
8
  72.7%
33
  61.1%
Male
4
  40.0%
4
  36.4%
7
  46.7%
3
  75.0%
0
   0.0%
3
  27.3%
21
  38.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 15 participants 4 participants 3 participants 11 participants 54 participants
10 11 15 4 3 11 54
1.Primary Outcome
Title Change in Hamilton Depression Rating Scale (HAM-D 17) Score
Hide Description

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.

Time Frame Visit 1 (Baseline) and Visit 17 (Week 9); Pilot Phase: Visit 1 (Baseline) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
3 randomized subjects excluded from TLT analyses because they received <4 t-PBM treatments. 2 study completers from Group 1(last visit out of window,started new treatment ),1 subject from Group 2(started therapy)excluded as completers in analyses. Pilot Study Treatment Group 2 excluded because there was no data(drop out, post screen ineligibility).
Arm/Group Title TLT Treatment Group 1 (Active TLT Treatment) TLT Treatment Group 2 (Placebo) TLT Treatment Group 1 (Active TLT Treatment) Completers TLT Treatment Group 2 (Placebo) Completers Pilot Study Treatment Group 1
Hide Arm/Group Description:

The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks

Near-infrared radiation via Transcranial LED Therapy: 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.

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

Sham device: The sham device does not emit near-infrared radiation.

The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks (completers only).

Near-infrared radiation via Transcranial LED Therapy: 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.

The sham group will receive 2 treatments of the sham device per week for 8 weeks. This only includes those who were followed for the entire 8-week study period and who received a clinical assessment immediately after.

Sham device: The sham device does not emit near-infrared radiation.

The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.

1 participant was missing a final visit 8 value, so LOCF was used for this value.

(see protocol change 10/28/2014)

Overall Number of Participants Analyzed 9 9 6 7 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.7  (7.47) -5.3  (7.03) -15.7  (4.41) -6.1  (7.86) -6.75  (4.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TLT Treatment Group 1 (Active TLT Treatment), TLT Treatment Group 2 (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments a priori threshold for statistical significance: p≤0.05
Method t-test, 1 sided
Comments We used a modified intent-to-treat approach with LOCF and unpaired Student’s t-test (one-way), comparing the change in total severity score.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TLT Treatment Group 1 (Active TLT Treatment), TLT Treatment Group 2 (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments a priori threshold for statistical significance: p≤0.05
Method t-test, 2 sided
Comments Modified intent-to-treat approach with lost observation carried forward (LOCF) and a two-tailed t-test to compare the change in total severity score.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TLT Treatment Group 1 (Active TLT Treatment) Completers, TLT Treatment Group 2 (Placebo) Completers
Comments This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments a priori threshold for statistical significance: p≤0.05
Method t-test, 1 sided
Comments One-tailed t-test to compare the change in total severity score for treatment completers.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection TLT Treatment Group 1 (Active TLT Treatment) Completers, TLT Treatment Group 2 (Placebo) Completers
Comments This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments a priori threshold for statistical significance: p≤0.05
Method t-test, 2 sided
Comments Two-tailed t-test to compare the change in total severity score for treatment completers.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pilot Study Treatment Group 1
Comments By means of a paired t-test we tested the significance of the change in the mean HAM-D17 total score (from baseline) to week 8. Although the primary comparison was with the last assessment (week 8). A last observation carried forward (LOCF) was also performed to account for one missing value at week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Systematic Assessment for Treatment Emergent Events-systematic Inquiry (SAFTEE-SI)
Hide Description

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.

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
3 subjects excluded from TLT because they received <4 t-PBM treatments.1 excluded from Group 1 due to unreliable reporting.1 Group 1 and 1 Group 2 excluded due to no final visit score.1 excluded from Pilot Study Treatment Group 1 due to no final visit score.Pilot Study Treatment Group 2 excluded due to no data(drop out, post screen ineligibility).
Arm/Group Title TLT Treatment Group 1 (Active TLT Treatment) TLT Treatment Group 2 (Placebo) Pilot Study Treatment Group 1
Hide Arm/Group Description:

The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks

Near-infrared radiation via Transcranial LED Therapy: 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.

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

Sham device: The sham device does not emit near-infrared radiation.

The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.

1 participant was missing a final visit 8 value, so LOCF was used for this value.

(see protocol change 10/28/2014)

Overall Number of Participants Analyzed 7 8 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
-17  (12.60) -9.38  (20.33) -10.33  (13.48)
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

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.

Time Frame Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17
Hide Outcome Measure Data
Hide Analysis Population Description
3 randomized subjects excluded from TLT analyses because they received <4 t-PBM treatments.
Arm/Group Title TLT Treatment Group 1 TLT Treatment Group 2 Pilot Study Treatment Group 1 Pilot Study Treatment Group 2
Hide Arm/Group Description:

The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks

Near-infrared radiation via Transcranial LED Therapy: 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.

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

Sham device: The sham device does not emit near-infrared radiation.

The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.

(see protocol change 10/28/2014)

The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.

(see protocol change 10/28/2014)

Overall Number of Participants Analyzed 9 9 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
7
  77.8%
2
  22.2%
1
  25.0%
1
  33.3%
4.Post-Hoc Outcome
Title Change in Quick Inventory of Depressive Symptomatology-Self Rated Scale (QIDS-SR) Score
Hide Description This is a brief (16-item) self-report inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. QIDS scores range from 0-27. Severity of depression can be judged based on the total score: 1-5 = No depression, 6-10 = Mild depression, 11-15 = Moderate depression. 16-20 = Severe depression, 21-27 = Very severe depression. Analyses were done for all evaluable subjects (participants who met the a priori cut-off of a minimum of four t-PBM sessions for inclusion in the study analyses) and treatment completers (participants who were followed for the entire 8-week study period and who received a clinical assessment immediately after). Pilot Study Group 2 excluded because no analyses were completed for this group (see participant flow)
Time Frame Visit 1 (Baseline) and Visit 17 (Week 9)
Hide Outcome Measure Data
Hide Analysis Population Description
Excluded: 3 randomized subjects who had <4 t-PBM treatments; 1 from Group 1 (unreliable reporting); 2 from Group 1 (started new treatment),1 from Group 2 (started therapy). 1 from Pilot study group 1 (no final visit). Pilot Study Group 2 excluded because there was no data (2 subjects dropped out, 1 subject ineligible--see Participant Flow).
Arm/Group Title TLT Treatment Group 1 (Active TLT Treatment) TLT Treatment Group 2 (Placebo) TLT Treatment Group 1 (Active TLT Treatment) Completers TLT Treatment Group 2 (Placebo) Completers Pilot Study Treatment Group 1
Hide Arm/Group Description:

The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks

Near-infrared radiation via Transcranial LED Therapy: 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.

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

Sham device: The sham device does not emit near-infrared radiation.

The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks (completers only).

Near-infrared radiation via Transcranial LED Therapy: 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.

The sham group will receive 2 treatments of the sham device per week for 8 weeks. This only includes those who were followed for the entire 8-week study period and who received a clinical assessment immediately after.

Sham device: The sham device does not emit near-infrared radiation.

The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.

(see protocol change 10/28/2014)

Overall Number of Participants Analyzed 8 9 5 7 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.9  (6.29) -3.7  (2.91) -9.8  (4.09) -4.3  (3.04) -2.33  (4.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TLT Treatment Group 1 (Active TLT Treatment), TLT Treatment Group 2 (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments a priori threshold for statistical significance: p≤0.05
Method t-test, 1 sided
Comments Last observation carried forward (LOCF), one tailed t-test to compare change in QIDS score.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TLT Treatment Group 1 (Active TLT Treatment) Completers, TLT Treatment Group 2 (Placebo) Completers
Comments This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments a priori threshold for statistical significance: p≤0.05
Method t-test, 1 sided
Comments One-tailed t-test to measure the change in QIDS score for treatment completers.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TLT Treatment Group 1 (Active TLT Treatment) Completers, TLT Treatment Group 2 (Placebo) Completers
Comments This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments a priori threshold for statistical significance: p≤0.05
Method t-test, 2 sided
Comments Two-tailed t-test measuring change in QIDS score for treatment completers.
Time Frame Adverse events were collected for the duration of the study. Study clinicians inquired about any adverse events once a week for all 8 weeks of treatment. Clinicians also asked about adverse events at Visit 17 (follow up visit after the 8 week treatment).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TLT Treatment Group 1 TLT Treatment Group 2 Pilot Study Treatment Group 1 Pilot Study Treatment Group 2
Hide Arm/Group Description

The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks

Near-infrared radiation via Transcranial LED Therapy: 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.

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

Sham device: The sham device does not emit near-infrared radiation.

The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks.

(see protocol change 10/28/2014)

The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks.

(see protocol change 10/28/2014)

All-Cause Mortality
TLT Treatment Group 1 TLT Treatment Group 2 Pilot Study Treatment Group 1 Pilot Study Treatment Group 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TLT Treatment Group 1 TLT Treatment Group 2 Pilot Study Treatment Group 1 Pilot Study Treatment Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/11 (0.00%)      0/4 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TLT Treatment Group 1 TLT Treatment Group 2 Pilot Study Treatment Group 1 Pilot Study Treatment Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/10 (70.00%)      2/11 (18.18%)      1/4 (25.00%)      1/3 (33.33%)    
Gastrointestinal disorders         
gastro-intestinal sickness   1/10 (10.00%)  1 0/11 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
abdominal bloating   1/10 (10.00%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
General disorders         
restless sleep   1/10 (10.00%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
headaches   1/10 (10.00%)  1 1/11 (9.09%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
taste illusion   1/10 (10.00%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
gout   1/10 (10.00%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
insomnia   2/10 (20.00%)  2 1/11 (9.09%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Irritability   2/10 (20.00%)  3 0/11 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
visual illusions (vivid colors)   2/10 (20.00%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
decreased memory; word finding difficulties   1/10 (10.00%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
left torso pain   0/10 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
belching   0/10 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
pressure/pain on back of head during 4T Scan   0/10 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
dizziness/tingling sensation in head   0/10 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Psychiatric disorders         
self-harm   1/10 (10.00%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Paolo Cassano
Organization: Massachusetts General Hospital
Phone: 617-643-9622
Responsible Party: Paolo Cassano, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01538199     History of Changes
Other Study ID Numbers: 2010P002718
2010A050442 ( Other Identifier: Harvard Medical School )
First Submitted: February 17, 2012
First Posted: February 24, 2012
Results First Submitted: January 9, 2017
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017