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Schizophrenia | Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

Schizophrenia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Schizophrenia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Aripiprazole

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

placeborisperidone plus placebo

aripiprazole 5mgrisperidone treatment plus aripiprazole 5mg/day

aripiprazole 10mgrisperidone plus aripiprazole 10mg/day

aripiprazole 20mgrisperidone plus aripiprazole 20mg/day

Study Status

Unknown status

Start Date: February 2013

Completed Date: February 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Prolactin level

Secondary Outcome: PANSS (positive and negative syndrome scale) score

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Beijing HuiLongGuan Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02013232

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