Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia
Information source: Beijing HuiLongGuan Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Aripiprazole (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Beijing HuiLongGuan Hospital Overall contact: Jingxu Chen, master, Phone: 86-13681394260, Email: chenjx1110@163.com
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.
Clinical Details
Official title: Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Prolactin level
Secondary outcome: PANSS (positive and negative syndrome scale) score
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Jingxu Chen, master, Phone: 86-13681394260, Email: chenjx1110@163.com
Beijing HuiLongGuan Hospital, Beijing, Beijing 102208, China; Recruiting Jingxu Chen, Phone: 86-13681394260, Email: chenjx1110@163.com Jingxu Chen, Principal Investigator
Additional Information
Starting date: February 2013
Last updated: December 11, 2013
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