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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to find out what parts of the brain have increased or decreased connectivity when people are depressed and how Seroquel extended release (XR) changes this connectivity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain.
This study will measure the activity and connectivity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with seroquel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label Quetiapine | Other | Open-label Quetiapine XL 50 - 400 mg daily treatment 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine (Seroquel XR) | Drug | Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 17-item Hamilton Depression Rating Scale (HDRS) | Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50. | Started: March 2009 Ending March 2011 |
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Inclusion Criteria:
Provision of written informed consent
A diagnosis of Major Depressive Episode by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
Females or Males aged 18 - 60 years
Female subjects of childbearing potential must be using a reliable method of contraception and have a negative serum human chorionic gonadotropin (HCG) test at enrollment
Able to understand and comply with the requirements of the study
17-item Hamilton Depression Rating Scale (HDRS) score > 15
Hamilton Anxiety Scale (HAM-A) score > 15
Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire
Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Anand, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Adult Psychiatry Clinic | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Seroquel XR | Seroquel XR (quetiapine) starting dose 50 mg and increased up to 400 mg as tolerated) treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine | quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment. |
| 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 |
| 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 | 17-item Hamilton Depression Rating Scale (HDRS) | Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50. | Posted | Mean | Standard Deviation | units on a scale | Started: March 2009 Ending March 2011 |
|
|
Adverse event data were collected for 12 weeks.
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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 | Quetiapine | quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | Nervous system disorders | Systematic Assessment |
Open label study. Small sample
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amit Anand | Indiana University | 317-274-7422 | aanand@iupui.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 20 |
| 18 |
| 20 |
| Irritability | Nervous system disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| increased sleep | Nervous system disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| dry mouth | Nervous system disorders | Systematic Assessment |
|
| urinary frequency | Renal and urinary disorders | Systematic Assessment |
|
| blurred vision | Nervous system disorders | Systematic Assessment |
|
| indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| increased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| decreased sleep | Nervous system disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| fluid retention | Vascular disorders | Systematic Assessment |
|
| twitching | Nervous system disorders | Systematic Assessment |
|
| sweating | Nervous system disorders | Systematic Assessment |
|
| hand dryness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| tremor | Nervous system disorders | Systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| increased thirst | Gastrointestinal disorders | Systematic Assessment |
|
| hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| nose congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| fainting | Nervous system disorders | Systematic Assessment |
|
| decreased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | Systematic Assessment |
|
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| D001519 |
| Behavior |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |