Environmental Treatment for Seasonal Affective Disorder (SAD)

Seasonal Affective Disorder Clinical Trial

Official title:

A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy For Seasonal Affective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139997
• Other study ID #: 22,777
• Secondary ID: 22,777
• Status: Completed
• Phase: N/A
• First received: August 29, 2005
• Last updated: January 29, 2013
• Start date: January 2002
• Est. completion date: August 2005

Study information

• Verified date: January 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose is to study treatments of Seasonal Affective Disorder (SAD).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mood Disorders
• Seasonal Affective Disorder

Intervention

Device:
• Litebook treatment devices
Litebook LED phototherapy device used for 30 min before 8 am
• Inactivated negative ion generator
Equivalent exposure to inactivated negative ion generator

Locations

Country	Name	City	State
Canada	Douglas Hospital Research Centre	Montreal	Quebec
Canada	Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada	Ottawa	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Netherlands	University Medical Center Groningen	Groningen	RB
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (5)

Lead Sponsor	Collaborator
Yale University	Douglas Hospital Research Centre, Royal Ottawa Mental Health Centre, University Medical Center Groningen, University of British Columbia

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version	SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.; Calculated: SIGH SAD score at trial end x 100 / SIGH SAD score at randomization	Week 4	No
Secondary	SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version	SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.	Weekly following randomization	No