Environmental Treatment for Seasonal Affective Disorder (SAD)
- Conditions
- Seasonal Affective Disorder
- Interventions
- Device: Litebook treatment devicesDevice: Inactivated negative ion generator
- Registration Number
- NCT00139997
- Lead Sponsor
- Yale University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Subjects meet DSM-IV criteria for major depressive episodes with a seasonal pattern, winter type.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LED phototherapy device Litebook treatment devices Litebook treatment devices: LED phototherapy device, used for 30 min before 8 am Inactivated Negative Ion Generator Inactivated negative ion generator Equivalent exposure to inactivated negative ion generator
- Primary Outcome Measures
Name Time Method Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version Week 4 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
- Secondary Outcome Measures
Name Time Method SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version Weekly following randomization 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.
Trial Locations
- Locations (5)
Douglas Hospital Research Centre
π¨π¦Montreal, Quebec, Canada
University Medical Center Groningen
π³π±Groningen, RB, Netherlands
University of British Columbia
π¨π¦Vancouver, British Columbia, Canada
Yale University School of Medicine
πΊπΈNew Haven, Connecticut, United States
Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada
π¨π¦Ottawa, Ontario, Canada