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Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial

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: NCT00852592
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : November 6, 2016
Last Update Posted : November 6, 2016
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Dorothy Sit, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Major Depressive Episode
Interventions Device: 7000lux broad-spectrum light
Device: 50lux dim red light
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Light Unit Inactive Light Unit
Hide Arm/Group Description active light therapy unit: dosage - 15-60minutes NOON-2PM daily Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
Period Title: Overall Study
Started 23 23
Completed 20 19
Not Completed 3 4
Arm/Group Title Active Comparator Inactive Comparator Total
Hide Arm/Group Description

active light unit

active light therapy unit: dosage - 15-60minutes NOON-2PM daily

inactive light unit

Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily

Total of all reporting groups
Overall Number of Baseline Participants 23 23 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
23
 100.0%
46
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 23 participants 46 participants
43  (12) 45  (15) 44  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
Female
15
  65.2%
16
  69.6%
31
  67.4%
Male
8
  34.8%
7
  30.4%
15
  32.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 23 participants 46 participants
23 23 46
SIGH-ADS depression score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 23 participants 46 participants
26.1  (5.2) 30.1  (6.1) 28.1  (5.9)
[1]
Measure Description: The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.
Global Assessment of Functioning (GAF)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 23 participants 46 participants
57.4  (5.61) 53.5  (5.32) 55.4  (5.76)
[1]
Measure Description: The Global Assessment of Function (GAF) was used to assess psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.
1.Primary Outcome
Title SIGH-ADS Depression Score
Hide Description The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Light Unit Inactive Light Unit
Hide Arm/Group Description:
active light therapy unit: dosage - 15-60minutes NOON-2PM daily
Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.3  (8.18) 17.3  (9.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Light Unit, Inactive Light Unit
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.005
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Global Assessment of Functioning (GAF)
Hide Description The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.
Time Frame 6-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Light Unit Inactive Light Unit
Hide Arm/Group Description:
active light therapy unit: dosage - 15-60minutes NOON-2PM daily
Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
73.9  (9.77) 65.2  (9.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Light Unit, Inactive Light Unit
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.004
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Comparator Inactive Comparator
Hide Arm/Group Description

active light unit

active light therapy unit: dosage - 15-60minutes NOON-2PM daily

inactive light unit Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
All-Cause Mortality
Active Comparator Inactive Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Active Comparator Inactive Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Comparator Inactive Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Assistant Professor of Psychiatry
Organization: UPittsburgh
Phone: 412-246-5248
EMail: sitdk@upmc.edu
Layout table for additonal information
Responsible Party: Dorothy Sit, Northwestern University
ClinicalTrials.gov Identifier: NCT00852592    
Other Study ID Numbers: PRO09020546
First Submitted: February 25, 2009
First Posted: February 27, 2009
Results First Submitted: February 19, 2016
Results First Posted: November 6, 2016
Last Update Posted: November 6, 2016