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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
This is a single center, open prospective study to evaluate the effectiveness of quetiapine monotherapy in the maintenance treatment of adolescent patients with a bipolar spectrum disorder (bipolar I and bipolar II disorders, cyclothymia, and bipolar disorder not otherwise specified [bipolar NOS]) for a minimum of 48 weeks. Patients will be screened (enrolment phase) either when already stabilized or during an acute episode of mania/hypomania or depression.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treated study patients maintained on monotherapy for the duration of the trial compared to the proportion requiring systematic adjunctive medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to an episode recurrence (Montgomery-Asberg Depression Rating Scale | ||
| /Young Mania Rating Scale [MADRS/YMRS] > 15) | ||
| Time to hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Grof, M.D. | Mood Disorders Center of Ottawa | Principal Investigator |
| Anne Duffy, M.D. | Mood Disorders Center of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mood Disorders Center of Ottawa | Ottawa | Ontario | K1G 4G3 | Canada |
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| 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 |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Autobiographical Memory Interview (AMI) mean score over treatment |
| Clinical Global Impression-Bipolar Disorder (CGI-BP) score during treatment and at study completion |
| YMRS total score during treatment and at study completion |
| MADRS total score during treatment and at study completion |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |