Seasonal Affective Disorder
Conditions
Keywords
SAD, winter depression
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.
Interventions
DEVICENegative Ion Generator
Equivalent exposure to inactivated Negative Ion Generator
DEVICELight-emitting Photodiode light treatment device
Light-emitting Photodiode light treatment device, used for 30 min before 8 am
Sponsors
The Litebook Company Ltd.
University of British Columbia
McGill University Health Centre/Research Institute of the McGill University Health Centre
Harvard University
University of Toronto
Clinical Associates Research, Maryland
Dalhousie University
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
* Seasonal Affective Disorder * Age 18 to 65
Exclusion criteria
* Psychotropic medication treatment * History of light treatment for SAD * History of mania or psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change SIGH SAD Depression Rating | 4 weeks | 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 - SIGH SAD score at randomization x 100 / SIGH SAD score at randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SIGH SAD Depression Rating | Weekly | 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. |
| Clinical Global Impression of Severity | Randomization and at 4 weeks | The Clinical Global Impression of Severity is a 7-point scale in which the clinician gives an overall impression of depression severity, with the following anchor points: (1)Normal, not at all ill, (2)Borderline ill, (3) Mildly ill, (4)Moderately ill, (5) Markedly ill, (6)Severely ill, and (7)Among the most severely ill patients. The minimum is therefore 1 and the maximum is 7, which represents very severe depression. |
Countries
Canada, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inactivated Negative Ion Generator Equivalent exposure to inactivated Negative Ion Generator | 54 |
| LED Phototherapy Device Light-emitting photodiode light treatment device, used for 30 min before 8 am | 52 |
| Total | 106 |
Baseline characteristics
| Characteristic | Inactivated Negative Ion Generator | LED Phototherapy Device | 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 | 54 Participants | 52 Participants | 106 Participants |
| Region of Enrollment Canada | 26 participants | 25 participants | 51 participants |
| Region of Enrollment Netherlands | 8 participants | 9 participants | 17 participants |
| Region of Enrollment United States | 20 participants | 18 participants | 38 participants |
| Sex: Female, Male Female | 42 Participants | 38 Participants | 80 Participants |
| Sex: Female, Male Male | 12 Participants | 14 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 54 | 7 / 52 |
| serious Total, serious adverse events | 0 / 54 | 0 / 52 |
Outcome results
Primary
Percentage Change SIGH SAD Depression Rating
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 - SIGH SAD score at randomization x 100 / SIGH SAD score at randomization
Time frame: 4 weeks
Population: Intent to treat analysis last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inactivated Negative Ion Generator | Percentage Change SIGH SAD Depression Rating | -36.4 percentage of change on SIGH SAD | Standard Deviation 34.9 |
| LED Phototherapy Device | Percentage Change SIGH SAD Depression Rating | -52.7 percentage of change on SIGH SAD | Standard Deviation 31.7 |
p-value: 0.014t-test, 2 sided
Secondary
Clinical Global Impression of Severity
The Clinical Global Impression of Severity is a 7-point scale in which the clinician gives an overall impression of depression severity, with the following anchor points: (1)Normal, not at all ill, (2)Borderline ill, (3) Mildly ill, (4)Moderately ill, (5) Markedly ill, (6)Severely ill, and (7)Among the most severely ill patients. The minimum is therefore 1 and the maximum is 7, which represents very severe depression.
Time frame: Randomization and at 4 weeks
Population: intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inactivated Negative Ion Generator | Clinical Global Impression of Severity | Randomization | 4.2 units on a scale | Standard Deviation 0.6 |
| Inactivated Negative Ion Generator | Clinical Global Impression of Severity | Week 4 | 3.0 units on a scale | Standard Deviation 1.3 |
| LED Phototherapy Device | Clinical Global Impression of Severity | Randomization | 4.2 units on a scale | Standard Deviation 0.7 |
| LED Phototherapy Device | Clinical Global Impression of Severity | Week 4 | 2.4 units on a scale | Standard Deviation 1.2 |
Comparison: Data were analyzed at the follow up timepoint (4 weeks) to test for differences between the experimental groups.p-value: 0.007t-test, 2 sided
Secondary
SIGH SAD Depression Rating
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
Population: Intent to treat analysis last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inactivated Negative Ion Generator | SIGH SAD Depression Rating | Randomization | 28.6 units on a scale | Standard Deviation 6.7 |
| Inactivated Negative Ion Generator | SIGH SAD Depression Rating | Week 2 | 19.9 units on a scale | Standard Deviation 9.3 |
| Inactivated Negative Ion Generator | SIGH SAD Depression Rating | Week 1 | 23.6 units on a scale | Standard Deviation 8.7 |
| Inactivated Negative Ion Generator | SIGH SAD Depression Rating | Week 3 | 18.6 units on a scale | Standard Deviation 9.7 |
| Inactivated Negative Ion Generator | SIGH SAD Depression Rating | Week 4 | 17.9 units on a scale | Standard Deviation 10.2 |
| LED Phototherapy Device | SIGH SAD Depression Rating | Week 3 | 15.8 units on a scale | Standard Deviation 8.3 |
| LED Phototherapy Device | SIGH SAD Depression Rating | Week 4 | 13.3 units on a scale | Standard Deviation 9.2 |
| LED Phototherapy Device | SIGH SAD Depression Rating | Randomization | 27.7 units on a scale | Standard Deviation 4.8 |
| LED Phototherapy Device | SIGH SAD Depression Rating | Week 1 | 20.9 units on a scale | Standard Deviation 7 |
| LED Phototherapy Device | SIGH SAD Depression Rating | Week 2 | 17.4 units on a scale | Standard Deviation 7.8 |