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Enrollment goals not met
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| Name | Class |
|---|---|
| Shire | INDUSTRY |
| University of Cincinnati | OTHER |
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The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine | Active Comparator | Drug |
|
| Placebo | Placebo Comparator | Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine | Drug | oral; 20-70mg/day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Montgomery-Asberg Depression Rating Scale | Efficacy will be assessed by measuring the baseline-to-endpoint change in the Montgomery-Asberg Depression Rating Scale (MADRS) | 30-36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindner Center of HOP | Mason | Ohio | 45040 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25340384 | Result | McElroy SL, Martens BE, Mori N, Blom TJ, Casuto LS, Hawkins JM, Keck PE Jr. Adjunctive lisdexamfetamine in bipolar depression: a preliminary randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Jan;30(1):6-13. doi: 10.1097/YIC.0000000000000051. |
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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 |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| Drug |
oral; 20-70mg/day |
|
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |