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Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Jingxu Chen, Beijing HuiLongGuan Hospital.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: December 17, 2013
Last Update Posted: December 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jingxu Chen, Beijing HuiLongGuan Hospital
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.

Condition Intervention
Schizophrenia Drug: Aripiprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study

Resource links provided by NLM:

Further study details as provided by Jingxu Chen, Beijing HuiLongGuan Hospital:

Primary Outcome Measures:
  • Prolactin level [ Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks ]
    Change from baseline in the levels of prolactin

Secondary Outcome Measures:
  • PANSS (positive and negative syndrome scale) score [ Time Frame: Baseline, 8 weeks ]
    Change from baseline in PANSS score

Other Outcome Measures:
  • extrapyramidal symptoms [ Time Frame: baseline, 4 weeks, 8 weeks ]
    assess the extrapyramidal symptoms

Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013232

Contact: Jingxu Chen, master 86-13681394260 chenjx1110@163.com

China, Beijing
Beijing HuiLongGuan Hospital Recruiting
Beijing, Beijing, China, 102208
Contact: Jingxu Chen    86-13681394260    chenjx1110@163.com   
Principal Investigator: Jingxu Chen         
Sponsors and Collaborators
Beijing HuiLongGuan Hospital
  More Information

Responsible Party: Jingxu Chen, associate professor, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier: NCT02013232     History of Changes
Other Study ID Numbers: ARI201206
First Submitted: December 2, 2013
First Posted: December 17, 2013
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Jingxu Chen, Beijing HuiLongGuan Hospital:
dose effects

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents