Trial Outcomes & Findings for Research Study of Treatment for Winter Depression With Different Colors of Light (NCT NCT00269633)

NCT ID: NCT00269633

Last Updated: 2016-03-28

Results Overview

Outcome for Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD) reported is the average over 3 weeks. Lower values represent less depressive symptoms. Range is 0-53.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: Averaged over Three Weeks During Treatment
• Results posted on: 2016-03-28

Participant Flow

Participant milestones

Measure	Red Light Box 657 nm LED Red Light Box 657 nm	Blue Light Box 467 nm LED Blue Light Box 467 nm
Overall Study STARTED	4	5
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Red Light Box 657 nm LED Red Light Box 657 nm	Blue Light Box 467 nm LED Blue Light Box 467 nm
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Research Study of Treatment for Winter Depression With Different Colors of Light

Baseline characteristics by cohort

Measure	Red Light Box n=3 Participants 657 nm Red Light Box: 657 nm Red LED Light	Blue Light Box n=5 Participants 467 nm Blue Light Box: 467 nm Blue LED Light	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.3 years STANDARD_DEVIATION 11.8 • n=5 Participants	39.2 years STANDARD_DEVIATION 10.8 • n=7 Participants	39.6 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Averaged over Three Weeks During Treatment

Outcome for Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD) reported is the average over 3 weeks. Lower values represent less depressive symptoms. Range is 0-53.

Outcome measures

Measure	Red Light Box 657 nm n=3 Participants LED Red Light Box 657 nm	Blue Light Box 467 nm n=5 Participants LED Blue Light Box 467 nm
Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks	16.3 units on a scale Standard Deviation 16.9	8 units on a scale Standard Deviation 3.6

Adverse Events

Red Light Box

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blue Light Box

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roseann Talarico

Thomas Jefferson University

Phone: 215 503 4743

Email: roseann.talarico@jefferson.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place