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| Name | Class |
|---|---|
| The Zucker Hillside Hospital | OTHER |
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This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis.
Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated and will lead to greater improvement in symptoms at the end of 6 months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antidepressant | Experimental | Fluoxetine |
|
| Antipsychotic | Active Comparator | Aripiprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antidepressant | Drug |
|
| |
| Antipsychotic |
| Measure | Description | Time Frame |
|---|---|---|
| Attenuated positive, negative and general psychiatric symptoms | To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Social and role functioning | To compare the effect of fluoxetine and aripiprazole on social and role functioning and subjective well-being in individuals at risk for schizophrenia. | 6 months |
| Time to all-cause discontinuation. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| D005473 | Fluoxetine |
| D014150 | Antipsychotic Agents |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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| Drug |
|
|
To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.
| 6 months |
| Adverse effects | To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects. | 6 months |
| D020164 | Chemical Actions and Uses |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D014149 | Tranquilizing Agents |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |