Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Litebook Company Ltd. | INDUSTRY |
| University of British Columbia | OTHER |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactivated negative ion generator | Experimental | Equivalent exposure to inactivated Negative Ion Generator |
|
| LED light treatment device | Experimental | Light-emitting photodiode light treatment device, used for 30 min before 8 am |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Ion Generator | Device | Equivalent exposure to inactivated Negative Ion Generator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Desan, MD, PhD | Yale University | Principal Investigator |
| Raymond Lam, MD | University of British Columbia, Vancouver, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06504 | United States | ||
| Capital Clinical Research Associates |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Inactivated Negative Ion Generator | Equivalent exposure to inactivated Negative Ion Generator |
| FG001 | LED Phototherapy Device | Light-emitting photodiode light treatment device, used for 30 min before 8 am |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Harvard University |
| OTHER |
| University of Toronto | OTHER |
| Clinical Associates Research, Maryland | NETWORK |
| Dalhousie University | OTHER |
Not provided
Not provided
Not provided
Not provided
| Light-emitting Photodiode light treatment device | Device | Light-emitting Photodiode light treatment device, used for 30 min before 8 am |
|
| Weekly |
| 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. | Randomization and at 4 weeks |
| Rockville |
| Maryland |
| 20852 |
| United States |
| McLean Hospital/Harvard | Belmont | Massachusetts | 02478 | United States |
| University of British Columbia | Vancouver | British Columbia | V6T 2A1 | Canada |
| St. John Regional Hospital | Saint John | New Brunswick | E2l 4L2 | Canada |
| CAMH/University of Toronto | Toronto | Ontario | M5T 1R8 | Canada |
| Sleep and Alertness Inc | Toronto | Ontario | Canada |
| University Medical Center Groningen | Groningen | RB | 9700 | Netherlands |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Inactivated Negative Ion Generator | Equivalent exposure to inactivated Negative Ion Generator |
| BG001 | LED Phototherapy Device | Light-emitting photodiode light treatment device, used for 30 min before 8 am |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat analysis last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Weekly |
|
|
| |||||||||||||||||||||||||||||||||||
| 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. | intent to treat analysis | Posted | Mean | Standard Deviation | units on a scale | Randomization and at 4 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| 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 | Intent to treat analysis last observation carried forward. | Posted | Mean | Standard Deviation | percentage of change on SIGH SAD | 4 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inactivated Negative Ion Generator | Equivalent exposure to inactivated Negative Ion Generator | 0 | 54 | 1 | 54 | ||
| EG001 | LED Phototherapy Device | Light-emitting photodiode light treatment device, used for 30 min before 8 am | 0 | 52 | 7 | 52 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye strain/glare | Nervous system disorders | Non-systematic Assessment |
| ||
| headache | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Desan, MD, PhD | Yale University | 203 785 2618 | paul.desan@yale.edu |
| ID | Term |
|---|---|
| D016574 | Seasonal Affective Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Netherlands |
|
| Canada |
|
| Week 2 |
|
| Week 3 |
|
| Week 4 |
|
|
|
|
|
|