Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

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

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aripiprazole

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102208
      • Recruiting
      • Beijing HuiLongGuan Hospital
      • Contact: Jingxu Chen; Phone Number: 86-13681394260; Email: chenjx1110@163.com
      • Principal Investigator: Jingxu Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; risperidone plus placebo
Experimental: aripiprazole 5mg; risperidone treatment plus aripiprazole 5mg/day	Drug: Aripiprazole
Experimental: aripiprazole 10mg; risperidone plus aripiprazole 10mg/day	Drug: Aripiprazole
Experimental: aripiprazole 20mg; risperidone plus aripiprazole 20mg/day	Drug: Aripiprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolactin level	Change from baseline in the levels of prolactin	baseline, 2 weeks, 4 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PANSS (positive and negative syndrome scale) score	Change from baseline in PANSS score	Baseline, 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
extrapyramidal symptoms	assess the extrapyramidal symptoms	baseline, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: Beijing HuiLongGuan Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimate): December 17, 2013

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Risperidone;; Aripiprazole;; Hyperprolactinemia;; dose effects
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Hypothalamic Diseases; Hyperpituitarism; Pituitary Diseases; Schizophrenia; Hyperprolactinemia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: ARI201206