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Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

NCT ID: NCT02013232

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Risperidone; Aripiprazole; Hyperprolactinemia; dose effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

risperidone plus placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

aripiprazole 5mg

risperidone treatment plus aripiprazole 5mg/day

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

aripiprazole 10mg

risperidone plus aripiprazole 10mg/day

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

aripiprazole 20mg

risperidone plus aripiprazole 20mg/day

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

Interventions

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Aripiprazole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing HuiLongGuan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jingxu Chen

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingxu Chen, master

Role: CONTACT

Phone: 86-13681394260

Email: [email protected]

Facility Contacts

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Jingxu Chen

Role: primary

Other Identifiers

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ARI201206

Identifier Type: -

Identifier Source: org_study_id