Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

N/AUnknownNCT02013232

Beijing HuiLongGuan Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Schizophrenia

Interventions

AripiprazoleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Prolactin level

Change from baseline in the levels of prolactin

Time frame: baseline, 2 weeks, 4 weeks, 8 weeks

Secondary Outcomes

PANSS (positive and negative syndrome scale) score

Change from baseline in PANSS score

Time frame: Baseline, 8 weeks

Central Contacts

Jingxu Chen, master

CONTACT

86-13681394260 chenjx1110@163.com

Data from ClinicalTrials.gov

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