Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02013232

Enrollment

120

Registered

2013-12-17

Start date

2013-02-28

Completion date

2014-02-28

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Risperidone;, Aripiprazole;, Hyperprolactinemia;, dose effects

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.

Interventions

DRUGAripiprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Prolactin level	baseline, 2 weeks, 4 weeks, 8 weeks	Change from baseline in the levels of prolactin

Secondary

Measure	Time frame	Description
PANSS (positive and negative syndrome scale) score	Baseline, 8 weeks	Change from baseline in PANSS score

Other

Measure	Time frame	Description
extrapyramidal symptoms	baseline, 4 weeks, 8 weeks	assess the extrapyramidal symptoms

Countries

China

Contacts

Primary ContactJingxu Chen, master

chenjx1110@163.com86-13681394260

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026