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In this study, patients with major depressive disorder (MDD) who have insomnia symptom are treated with Seroquel XR in an open-label manner for a 4-week period with repeated measurements of insomnia symptoms and sleep parameters using polysomnography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seroquel XR | Experimental | Patients with MDD receives Seroquel XR. |
|
| healthy control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine Fumarate Extended Release | Drug | Day 1 50mg, Day 2 50mg, Day 3 150mg, Day 4~28 50~150mg (increments and deduction of 50mg are allowed) |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline Pittsburgh Quality Index total scores at 4 weeks | baseline and 4 weeks | |
| change from baseline Pittsburgh Quality Index total scores at 2 weeks | baseline and 2 weeks | |
| change from baseline Pittsburgh Quality Index total scores at 4 days | baseline and 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in sleep architecture measured using polysomnography at 4 weeks | baseline and at 4 weeks | |
| number of participants with adverse events | 4 weeks | |
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Patient Inclusion Criteria:
Healthy Control Subject Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inkyoon Lyoo, MD, PhD, MMS | Ewha Womans University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| number of participants with adverse events |
| 2 weeks |
| number of participants with adverse events | 4 days |