Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

Not Applicable

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole

• Registration Number: NCT02013232
• Lead Sponsor: Beijing HuiLongGuan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-12
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-11
• Last Update Submitted: 2013-12-11
• Study First Posted: 2013-12-17
• Last Update Posted: 2013-12-17
• Primary Completion: 2014-01
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aripiprazole 5mg	Aripiprazole	risperidone treatment plus aripiprazole 5mg/day
aripiprazole 10mg	Aripiprazole	risperidone plus aripiprazole 10mg/day
aripiprazole 20mg	Aripiprazole	risperidone plus aripiprazole 20mg/day

Primary Outcome Measures

Name	Time	Method
Prolactin level	baseline, 2 weeks, 4 weeks, 8 weeks	Change from baseline in the levels of prolactin

Secondary Outcome Measures

Name	Time	Method
PANSS (positive and negative syndrome scale) score	Baseline, 8 weeks	Change from baseline in PANSS score

Trial Locations

Locations (1)

Beijing HuiLongGuan Hospital; 🇨🇳 Beijing, Beijing, China