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| ID | Type | Description | Link |
|---|---|---|---|
| 22,777 | Other Identifier | Yale University |
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| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
| University of British Columbia | OTHER |
| Royal Ottawa Mental Health Centre | UNKNOWN |
| Douglas Hospital Research Centre |
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The purpose is to study treatments of Seasonal Affective Disorder (SAD).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LED phototherapy device | Experimental | Litebook treatment devices: LED phototherapy device, used for 30 min before 8 am |
|
| Inactivated Negative Ion Generator | Placebo Comparator | Equivalent exposure to inactivated negative ion generator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Litebook treatment devices | Device | Litebook LED phototherapy device used for 30 min before 8 am |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul H. Desan, PhD, MD | Yale New Haven Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06504 | United States | ||
| University of British Columbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17683643 | Result | 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 Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38. |
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| ID | Title | Description |
|---|---|---|
| FG000 | LED Phototherapy | Phototherapy with light-emitting diode phototherapy device |
| FG001 | Inactive Intervention | Equivalent exposure to inactive negative ion generator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LED Phototherapy | Phototherapy with light-emitting diode phototherapy device |
| BG001 | Inactive Intervention | Equivalent exposure to inactive negative ion generator |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | These participants are analyzed ITT- last observation carried forward. | Posted | Mean | Standard Deviation | Percentage of SIGH SAD | Week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LED Phototherapy | Phototherapy with light-emitting diode phototherapy device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Desan, MD, PhD | Yale University | 203 785 2618 | paul.desan@yale.edu |
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| ID | Term |
|---|---|
| D016574 | Seasonal Affective Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| UNKNOWN |
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| Inactivated negative ion generator | Device | Equivalent exposure to inactivated negative ion generator |
|
| Weekly following randomization |
| Vancouver |
| British Columbia |
| V6T 2A1 |
| Canada |
| Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada | Ottawa | Ontario | K1Z 7K4 | Canada |
| Douglas Hospital Research Centre | Montreal | Quebec | H4H 1R3 | Canada |
| University Medical Center Groningen | Groningen | RB | 9700 | Netherlands |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG001 | Inactive Intervention | Equivalent exposure to inactive negative ion generator |
|
|
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| 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. | These participants are analyzed ITT- last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Weekly following randomization |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | Inactive Intervention | Equivalent exposure to inactive negative ion generator | 0 | 11 | 1 | 11 |
| dry mouth | General disorders | Systematic Assessment |
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| jitteriness | Psychiatric disorders | Systematic Assessment |
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| difficulty falling asleep | Psychiatric disorders | Systematic Assessment |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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