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Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric emergencies and is associated with significant morbidity and mortality. The purpose of the study is to evaluate the safety and efficacy of open-label memantine in the acute management of adults with bipolar I disorder hospitalized for mania.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine HCl | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Young Mania Rating Scale (YMRS) | ||
| Mania Rating Scale | ||
| Clinical Global Impression | ||
| Montgomery Asberg Depression Rating Scale | ||
| Positive and Negative Syndrome Scale (PANSS) | ||
| PANSS - Excited Component |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synergy Clinical Research Center | National City | California | 91950 | United States | ||
| Sheppard Pratt Health System |
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| Baltimore |
| Maryland |
| 21204 |
| United States |
| St. Charles Psychiatric Associates | Saint Charles | Missouri | 63301 | United States |
| Psychiatric Professional Services, Inc. | Cincinnati | Ohio | 45267-0559 | United States |
| Rebecca Sealy Hospital | Galveston | Texas | 77555-0197 | United States |
| University Hills Clinical Research | Irving | Texas | 75062 | United States |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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