Trial Outcomes & Findings for Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial (NCT NCT00852592)

Last Updated: 2016-11-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

46 participants

Primary outcome timeframe

6 weeks

Results posted on

2016-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	23	23
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator n=23 Participants active light unit active light therapy unit: dosage - 15-60minutes NOON-2PM daily	Inactive Comparator n=23 Participants inactive light unit Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	43 years STANDARD_DEVIATION 12 • n=93 Participants	45 years STANDARD_DEVIATION 15 • n=4 Participants	44 years STANDARD_DEVIATION 13 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	16 Participants n=4 Participants	31 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Region of Enrollment United States	23 participants n=93 Participants	23 participants n=4 Participants	46 participants n=27 Participants
SIGH-ADS depression score	26.1 units on a scale STANDARD_DEVIATION 5.2 • n=93 Participants	30.1 units on a scale STANDARD_DEVIATION 6.1 • n=4 Participants	28.1 units on a scale STANDARD_DEVIATION 5.9 • n=27 Participants
Global Assessment of Functioning (GAF)	57.4 units on a scale STANDARD_DEVIATION 5.61 • n=93 Participants	53.5 units on a scale STANDARD_DEVIATION 5.32 • n=4 Participants	55.4 units on a scale STANDARD_DEVIATION 5.76 • n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Active Light Unit n=23 Participants active light therapy unit: dosage - 15-60minutes NOON-2PM daily	Inactive Light Unit n=23 Participants Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
SIGH-ADS Depression Score	10.3 units on a scale Standard Deviation 8.18	17.3 units on a scale Standard Deviation 9.53

SECONDARY outcome

Timeframe: 6-weeks

The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.

Outcome measures

Outcome measures
Measure	Active Light Unit n=23 Participants active light therapy unit: dosage - 15-60minutes NOON-2PM daily	Inactive Light Unit n=23 Participants Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
Global Assessment of Functioning (GAF)	73.9 units on a scale Standard Deviation 9.77	65.2 units on a scale Standard Deviation 9.83

Adverse Events

Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inactive Comparator

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

Assistant Professor of Psychiatry

UPittsburgh

Phone: 412-246-5248

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place