Seasonal Affective Disorder
Conditions
Keywords
Major Depression, Seasonal Affective Disorder (SAD)
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.
Interventions
DEVICELitebook treatment devices
Litebook LED phototherapy device used for 30 min before 8 am
Equivalent exposure to inactivated negative ion generator
Sponsors
University Medical Center Groningen
University of British Columbia
Royal Ottawa Mental Health Centre
Douglas Hospital Research Centre
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LED Phototherapy Phototherapy with light-emitting diode phototherapy device | 15 |
| Inactive Intervention Equivalent exposure to inactive negative ion generator | 11 |
| Total | 26 |
Baseline characteristics
| Characteristic | LED Phototherapy | Inactive Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 11 Participants | 26 Participants |
| Age Continuous | 42.9 years STANDARD_DEVIATION 11.4 | 44.9 years STANDARD_DEVIATION 10.4 | 43.7 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment Canada | 6 participants | 3 participants | 9 participants |
| Region of Enrollment Netherlands | 2 participants | 2 participants | 4 participants |
| Region of Enrollment United States | 7 participants | 6 participants | 13 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 15 | 1 / 11 |
| serious Total, serious adverse events | 0 / 15 | 0 / 11 |
Outcome results
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
Time frame: Week 4
Population: These participants are analyzed ITT- last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LED Phototherapy | Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | 34.5 Percentage of SIGH SAD | Standard Deviation 30.47 |
| Inactive Intervention | Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | 60.4 Percentage of SIGH SAD | Standard Deviation 23.61 |
p-value: 0.028t-test, 2 sided
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.
Time frame: Weekly following randomization
Population: These participants are analyzed ITT- last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LED Phototherapy | SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | Randomization | 28.0 units on a scale | Standard Deviation 5.3 |
| LED Phototherapy | SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | Week 4 | 8.7 units on a scale | Standard Deviation 8.4 |
| LED Phototherapy | SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | Week 1 | 18.6 units on a scale | Standard Deviation 7.9 |
| LED Phototherapy | SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | Week 2 | 14.9 units on a scale | Standard Deviation 10 |
| LED Phototherapy | SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | Week 3 | 11.1 units on a scale | Standard Deviation 10.1 |
| Inactive Intervention | SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | Week 2 | 17.9 units on a scale | Standard Deviation 4.9 |
| Inactive Intervention | SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | Week 3 | 14.9 units on a scale | Standard Deviation 4.2 |
| Inactive Intervention | SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | Week 4 | 13.4 units on a scale | Standard Deviation 5.4 |
| Inactive Intervention | SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | Randomization | 25.1 units on a scale | Standard Deviation 3.2 |
| Inactive Intervention | SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | Week 1 | 19.0 units on a scale | Standard Deviation 7.2 |