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

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. Identifier: NCT00269633
Recruitment Status : Completed
First Posted : December 23, 2005
Results First Posted : March 28, 2016
Last Update Posted : March 28, 2016
Apollo Health Systems
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Seasonal Affective Disorder
Interventions: Device: Blue Light Box 467 nm
Device: Red Light Box 657 nm

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Red Light Box 657 nm LED Red Light Box 657 nm
Blue Light Box 467 nm LED Blue Light Box 467 nm

Participant Flow:   Overall Study
    Red Light Box 657 nm   Blue Light Box 467 nm
STARTED   4   5 
COMPLETED   3   5 
Withdrawal by Subject                1                0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Red Light Box

657 nm

Red Light Box: 657 nm Red LED Light

Blue Light Box

467 nm

Blue Light Box: 467 nm Blue LED Light

Total Total of all reporting groups

Baseline Measures
   Red Light Box   Blue Light Box   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   5   8 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   3   5   8 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 40.3  (11.8)   39.2  (10.8)   39.6  (10.3) 
[Units: Participants]
Female   2   4   6 
Male   1   1   2 
Region of Enrollment 
[Units: Participants]
United States   3   5   8 

  Outcome Measures

1.  Primary:   Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks   [ Time Frame: Averaged over Three Weeks During Treatment ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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: Roseann Talarico
Organization: Thomas Jefferson University
phone: 215 503 4743


Responsible Party: Thomas Jefferson University Identifier: NCT00269633     History of Changes
Other Study ID Numbers: 080-19000-J11401
First Submitted: December 22, 2005
First Posted: December 23, 2005
Results First Submitted: May 18, 2015
Results First Posted: March 28, 2016
Last Update Posted: March 28, 2016