Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Beijing HuiLongGuan Hospital
Sponsor:
Information provided by (Responsible Party):
Jingxu Chen, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier:
NCT02013232
First received: December 2, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Beijing HuiLongGuan Hospital:

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


Secondary Outcome Measures:
  • PANSS (positive and negative syndrome scale) score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in PANSS score


Other Outcome Measures:
  • extrapyramidal symptoms [ Time Frame: baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013232

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

Locations
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

No publications provided

Responsible Party: Jingxu Chen, associate professor, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier: NCT02013232     History of Changes
Other Study ID Numbers: ARI201206
Study First Received: December 2, 2013
Last Updated: December 11, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing HuiLongGuan Hospital:
Risperidone;
Aripiprazole;
Hyperprolactinemia;
dose effects

Additional relevant MeSH terms:
Hyperprolactinemia
Schizophrenia
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Aripiprazole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 20, 2014