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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features. One group will receive a second generation antipsychotic (SGA) and placebo and the other will receive a SGA and lithium.
The primary double-blind phase of the study will last 8 weeks, followed by a 24-week extension-phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium/Adjunctive SGA | Experimental |
| |
| Placebo/Adjunctive SGA | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium treatment in combination with a SGA (Second Generation Antipsychotic) | Drug | All patients will be treated with aripiprazole with a target dose of 10 mg/day and a max daily dose of 30 mg. If aripiprazole is ineffective or not tolerated, it will be tapered and risperidone treatment will be started. If patient had an adequate aripiprazole trial in the past as described above, risperidone will be the initial treatment. Risperidone dosing will begin with 0.5 mg/day on day 1 with a target dose of 2.5 mg/day and a max daily dose of 6mg. Subjects in the lithium /adjunctive SGA group will be started at 900 mg/day lithium in thrice daily dosing. The lithium dose will be increased to 1200mg/day on day 4 if lithium has been well-tolerated and symptoms of mania remain, as determined by a phone assessment done by a blinded study physician. The target serum level of lithium will be 1.2 mEq/L (range 0.8 to 1.4 mEq/L). |
| Measure | Description | Time Frame |
|---|---|---|
| Acute phase :Time to partial or full response | Acute phase: Partial response is defined as at least a 25% -49% reduction in YMRS score and a CGI improvement item score of 2. Full response is defined as a reduction in YMRS score of 50% or more and a CGI improvement item score of 1 "very much improved." | 8 weeks |
| Continuation Phase: time to recurrence of a subsyndromal mood episode | We will measure the amount of time for patients to have a recurrance of a subsyndomal mood episode during the Continuation Phase | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acute phase: number of suicidal events | 8 weeks | |
| Acute phase: positive urine toxicology screens (yes/no variable) | 8 weeks | |
| Acute phase: adherence to medication regimen. |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Zucker Hillside Hospital, North Shore-LIJ Health System | Glen Oaks | New York | 11004 | United States |
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| Placebo/Adjunctive SGA treatment | Drug | All patients will be treated with aripiprazole with a target dose of 10 mg/day and a max daily dose of 30 mg. If aripiprazole is ineffective or not tolerated, it will be tapered and risperidone treatment will be started. If patient had an adequate aripiprazole trial in the past as described above, risperidone will be the initial treatment. Risperidone dosing will begin with 0.5 mg/day on day 1 with a target dose of 2.5 mg/day and a max daily dose of 6mg. Subjects in the placebo /adjunctive SGA group will receive placebo for the entire trial in addition to the adjunctive SGA. |
|
| 8 weeks |