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Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents and atypical antipsychotics such as risperidone. Recent studies have suggested that aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics. Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with risperidone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | risperidone plus placebo | |
| aripiprazole 5mg | Experimental | risperidone treatment plus aripiprazole 5mg/day |
|
| aripiprazole 10mg | Experimental | risperidone plus aripiprazole 10mg/day |
|
| aripiprazole 20mg | Experimental | risperidone plus aripiprazole 20mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prolactin level | Change from baseline in the levels of prolactin | baseline, 2 weeks, 4 weeks, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PANSS (positive and negative syndrome scale) score | Change from baseline in PANSS score | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| extrapyramidal symptoms | assess the extrapyramidal symptoms | baseline, 4 weeks, 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingxu Chen, master | Contact | 86-13681394260 | chenjx1110@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing HuiLongGuan Hospital | Recruiting | Beijing | Beijing Municipality | 102208 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D006966 | Hyperprolactinemia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |