Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

Beijing HuiLongGuan Hospital

Status: Unknown

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02013232

ARI201206

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. aged 18-45 years of and fulfilled Diagnostic and Statistical Manual of Mental Disorders(DSM-IV )criteria (American Psychiatric Association, 1994) for schizophrenia;
2. having a stable psychiatric condition, defined as taking the same dosage of risperidone for at least 6 weeks;
3. being treated with risperidone monotherapy; and presence of hyperprolactinemia associated with risperidone.

Exclusion criteria

1. any other major psychiatric disorder;
2. significant concurrent medical illnesses, organic brain disorder, history of substance and alcohol abuse, and mental retardation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

risperidone plus placebo

aripiprazole 5mg

Experimental group

Description:

risperidone treatment plus aripiprazole 5mg/day

Treatment:

Drug: Aripiprazole

aripiprazole 10mg

Experimental group

Description:

risperidone plus aripiprazole 10mg/day

Treatment:

Drug: Aripiprazole

aripiprazole 20mg

Experimental group

Description:

risperidone plus aripiprazole 20mg/day

Treatment:

Drug: Aripiprazole