Clinical trial NCT00809523: A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)
Official title: A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Seasonal Affective Disorder
Keywords: SAD
winter depression
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: The Litebook Company Ltd.
name: University of British Columbia
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Harvard University
name: University of Toronto
name: Clinical Associates Research, Maryland
name: Dalhousie University
First posted: 2008-12-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase and a 4 week treatment phase.

Detailed description: This is a randomized, controlled clinical trial comparing an inactivated negative ion generation (placebo condition) and light-emitting photodiode therapy (active condition), for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. Exclusion criteria included any other current treatment for SAD, as well as bipolar disorder, type 1, a chronic psychotic disorder, or a substance use not if full remission for at least one year. The trial has a 1 week baseline phase and subjects were seen weekly during a 4 week treatment phase. The study was double-blind. The study was conducted at 8 sites in the US, Canada and The Netherlands.

Eligibility criteria: Inclusion Criteria:

* Seasonal Affective Disorder
* Age 18 to 65

Exclusion Criteria:

* Psychotropic medication treatment
* History of light treatment for SAD
* History of mania or psychosis

Primary outcomes:
measure: Percentage Change SIGH SAD Depression Rating
timeFrame: 4 weeks
Secondary outcomes:
measure: SIGH SAD Depression Rating
timeFrame: Weekly
measure: Clinical Global Impression of Severity
timeFrame: Randomization and at 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Rockville
country: United States
facility: Capital Clinical Research Associates
state: Maryland
city: Belmont
country: United States
facility: McLean Hospital/Harvard
state: Massachusetts
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: St. John
country: Canada
facility: St. John Regional Hospital
state: New Brunswick
city: Toronto
country: Canada
facility: CAMH/University of Toronto
state: Ontario
city: Toronto
country: Canada
facility: Sleep and Alertness Inc
state: Ontario
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
state: RB
Study officials:
affiliation: Yale University
name: Paul Desan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia, Vancouver, Canada
name: Raymond Lam, MD
role: PRINCIPAL_INVESTIGATOR
References: