| Xu 2006 |
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Methods: Randomized, single-blind, placebo-controlled study. |
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Participants: All 60 female patients with schizophrenia, aged 18–35 years with chronic, stable condition. Who had serum prolactin levels ≥60 µg/L and oligomenorrhea or galactorrhea 3 months after risperidone or sulpiride treatment were enrolled. Patients were ineligible if they had any vital medical condition, especially endocrine disease, and had pregnancy within two years. |
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Interventions: Participants received adjunctive aripiprazole 5 mg daily or placebo for 6 weeks respectively. |
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Outcomes: Decreases in mean serum prolactin levels, the ratio of prolactin level normalization, and the incidence of side effects. |
| Shim 2007 |
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Methods: Randomized, double-blind, placebo-controlled study |
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Participants: Fifty-four patients with schizophrenia, either gender, ages 18 to 45, clinically stable, who had been treated with haloperidol monotherapy and were taking the same dosage of haloperidol for at least 3 months. Other eligibility requirements included the presence of hyperprolactinemia, no past history of drug or alcohol abuse, and no medical and/or neurological illness. |
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Interventions: Participants were randomly assigned to receive aripiprazole or placebo treatment. Aripiprazole was dosed at 15 mg/day for the first 4 weeks, and then increased to 30 mg/day for the following 4 weeks if it was clinically tolerated. |
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Outcomes: Decreases in mean serum prolactin levels, the ratio of prolactin level normalization, and the incidence of side effects. |
| Ji 2008 |
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Methods: Randomized, single-blind, placebo-controlled study. |
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Participants: All 130 female patients with schizophrenia, aged 18–35 years, with chronic, stable condition. Who had serum prolactin levels ≥60 µg/L after fixed dose risperidone treatment were enrolled. Patients were ineligible if they had any endocrine disease, and had pregnancy within two years. |
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Interventions: Participants received adjunctive aripiprazole 5 mg daily or placebo for 6 weeks respectively. |
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Outcomes: Decreases in mean serum prolactin levels, the decline rate and the normalization ratio of prolactin level, the incidence of side effects. |
| Chen 2009 |
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Methods: Double-blind, randomized, placebo-controlled study. |
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Participants: Seventy-two male patients with schizophrenia, ages 18 to 50, never taking antipsychotic drugs. All the patients were treated with risperidone for 4 weeks, and then patients whose prolactin level reached to 60 ug/L were enrolled. Patients were ineligible if they had any vital medical condition, drug or alcohol abuse and significant abnormal laboratory test. |
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Interventions: Participants were administered additional aripiprazole 5 mg daily or placebo for 8 weeks |
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Outcomes: Decreases in mean serum prolactin levels, the decline rate and the ratio of prolactin level normalization, the incidence of side effects. |
| Kane 2009 |
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Methods: Randomized, double-blind, placebo-controlled study in 43 American sites. |
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Participants: Outpatients of either gender, age≥18 years with chronic, stable schizophrenia or schizoaffective disorder and currently receiving a stable dose of quetiapine (400–800 mg/d) or risperidone (4–8 mg/d) for≥4 weeks but with an inadequate response were entered. Patients were ineligible if they had any medically significant abnormal laboratory test or vital sign. |
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Interventions: Participants were randomly assigned to receive aripiprazole (2–15 mg/d) or placebo for 16-week adjunctive therapy. |
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Outcomes: Improvement in psychiatric symptoms, decreases in serum prolactin levels, the ratio of prolactin level normalization, the incidence of side effects. |
