Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02013232
• Other study ID #: ARI201206
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2013
• Last updated: December 11, 2013
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: December 2013
• Source: Beijing HuiLongGuan Hospital
• Contact: Jingxu Chen, master
• Phone: 86-13681394260
• Email: chenjx1110[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperprolactinemia
• Schizophrenia

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
China	Beijing HuiLongGuan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing HuiLongGuan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	extrapyramidal symptoms	assess the extrapyramidal symptoms	baseline, 4 weeks, 8 weeks	Yes
Primary	Prolactin level	Change from baseline in the levels of prolactin	baseline, 2 weeks, 4 weeks, 8 weeks	Yes
Secondary	PANSS (positive and negative syndrome scale) score	Change from baseline in PANSS score	Baseline, 8 weeks	No