Clinical trial NCT00139997: Environmental Treatment 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Affective Disorder
Keywords: Major Depression
Seasonal Affective Disorder (SAD)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
name: University of British Columbia
name: Royal Ottawa Mental Health Centre
name: Douglas Hospital Research Centre
First posted: 2005-08-31
Enrollment: 26
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: The purpose is to study treatments of Seasonal Affective Disorder (SAD).

Detailed description: This is a multicenter, randomized controlled trial of negative ion generation versus light-emitting diode phototherapy for seasonal affective disorder. Participants appropriate for the study are subjects with a DSM IV diagnosis of Major Depression, with seasonal pattern, winter type. Subjects were seen at Yale University,New Haven,CT University of British Columbia,Vancouver,BC Groningen University Hospital,Groningen, The Netherlands, Royal Ottawa Hospital, Ottawa,Ontario, McGill University, Montreal,Quebec, University Hospital,Saskatoon, Saskatchewan. The trial is 4 weeks in duration.

This trial has now been completed.

Eligibility criteria: Inclusion Criteria:

* Subjects meet DSM-IV criteria for major depressive episodes with a seasonal pattern, winter type.

Exclusion Criteria:

* Significant suicidal risk
* Serious medical illness
* Pregnancy
* Other DSM-IV diagnoses
* Taking mood altering medication
* May not travel to a sunny destination during study

Primary outcomes:
measure: Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
timeFrame: Week 4
Secondary outcomes:
measure: SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
timeFrame: Weekly following randomization
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Ottawa
country: Canada
facility: Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada
state: Ontario
city: Montreal
country: Canada
facility: Douglas Hospital Research Centre
state: Quebec
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
state: RB
Study officials:
affiliation: Yale New Haven Hospital
name: Paul H. Desan, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.