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terminated due to very low recruitment rate (27 June 2006)
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The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | quetiapine fumarate monotherapy |
|
| 2 | Experimental | Quetiapine + sodium valproate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine fumarate | Drug | oral variable dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate) | after 2 weeks treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Rasmus Wenzer Licht | AstraZeneca | Principal Investigator |
| AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Copenhagen | Denmark | ||||
| Research Site |
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| sodium valproate | Drug | oral |
|
| Esbjerg |
| Denmark |
| Research Site | Frederikssund | Denmark |
| Research Site | Haderslev | Denmark |
| Research Site | Hellerup | Denmark |
| Research Site | Kolding | Denmark |
| Researcg Site | Svendborg | Denmark |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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