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

This study has been completed.
Apollo Health Systems
Information provided by (Responsible Party):
Thomas Jefferson University Identifier:
First received: December 22, 2005
Last updated: March 2, 2016
Last verified: March 2016
Results First Received: May 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Seasonal Affective Disorder
Interventions: Device: Blue Light Box 467 nm
Device: Red Light Box 657 nm

  Participant Flow
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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  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  

  Baseline Characteristics
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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  
Number of Participants  
[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
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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
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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
Study First Received: December 22, 2005
Results First Received: May 18, 2015
Last Updated: March 2, 2016
Health Authority: United States: Institutional Review Board