Back to resultsAdjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Risperidone;, Aripiprazole;, Hyperprolactinemia;, dose effects
Eligibility Criteria
Inclusion Criteria:
- aged 18-45 years of and fulfilled Diagnostic and Statistical Manual of Mental Disorders(DSM-IV )criteria (American Psychiatric Association, 1994) for schizophrenia;
- having a stable psychiatric condition, defined as taking the same dosage of risperidone for at least 6 weeks;
- being treated with risperidone monotherapy; and presence of hyperprolactinemia associated with risperidone.
Exclusion Criteria:
- any other major psychiatric disorder;
- significant concurrent medical illnesses, organic brain disorder, history of substance and alcohol abuse, and mental retardation
Sites / Locations
- Beijing HuiLongGuan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
placebo
aripiprazole 5mg
aripiprazole 10mg
aripiprazole 20mg
Arm Description
risperidone plus placebo
risperidone treatment plus aripiprazole 5mg/day
risperidone plus aripiprazole 10mg/day
risperidone plus aripiprazole 20mg/day
Outcomes
Primary Outcome Measures
Prolactin level
Change from baseline in the levels of prolactin
Secondary Outcome Measures
PANSS (positive and negative syndrome scale) score
Change from baseline in PANSS score
Full Information
NCT ID
NCT02013232
First Posted
December 2, 2013
Last Updated
December 11, 2013
Sponsor
Beijing HuiLongGuan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02013232
Brief Title
Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia
Official Title
Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing HuiLongGuan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Risperidone;, Aripiprazole;, Hyperprolactinemia;, dose effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
risperidone plus placebo
Arm Title
aripiprazole 5mg
Arm Type
Experimental
Arm Description
risperidone treatment plus aripiprazole 5mg/day
Arm Title
aripiprazole 10mg
Arm Type
Experimental
Arm Description
risperidone plus aripiprazole 10mg/day
Arm Title
aripiprazole 20mg
Arm Type
Experimental
Arm Description
risperidone plus aripiprazole 20mg/day
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
Prolactin level
Description
Change from baseline in the levels of prolactin
Time Frame
baseline, 2 weeks, 4 weeks, 8 weeks
Secondary Outcome Measure Information:
Title
PANSS (positive and negative syndrome scale) score
Description
Change from baseline in PANSS score
Time Frame
Baseline, 8 weeks
Other Pre-specified Outcome Measures:
Title
extrapyramidal symptoms
Description
assess the extrapyramidal symptoms
Time Frame
baseline, 4 weeks, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18-45 years of and fulfilled Diagnostic and Statistical Manual of Mental Disorders(DSM-IV )criteria (American Psychiatric Association, 1994) for schizophrenia;
having a stable psychiatric condition, defined as taking the same dosage of risperidone for at least 6 weeks;
being treated with risperidone monotherapy; and presence of hyperprolactinemia associated with risperidone.
Exclusion Criteria:
any other major psychiatric disorder;
significant concurrent medical illnesses, organic brain disorder, history of substance and alcohol abuse, and mental retardation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingxu Chen, master
Phone
86-13681394260
Email
chenjx1110@163.com
Facility Information:
Facility Name
Beijing HuiLongGuan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102208
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingxu Chen
Phone
86-13681394260
Email
chenjx1110@163.com
First Name & Middle Initial & Last Name & Degree
Jingxu Chen
12. IPD Sharing Statement
Learn more about this trial
Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia
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