CClinicalTrials.gg
Status unknownNCT02013232Updated Dec 17, 2013

Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

An interventional study of Aripiprazole in Schizophrenia, sponsored by Beijing HuiLongGuan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-12-17.

Sponsored by Beijing HuiLongGuan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia

Keywords

  • Risperidone;
  • Aripiprazole;
  • Hyperprolactinemia;
  • dose effects
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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

Interventions

  • DrugAripiprazole
05

What researchers measure

Primary outcomes

  1. Prolactin level

    Change from baseline in the levels of prolactin

    Time frame: baseline, 2 weeks, 4 weeks, 8 weeks

Secondary outcomes

  1. PANSS (positive and negative syndrome scale) score

    Change from baseline in PANSS score

    Time frame: Baseline, 8 weeks

Other outcomes

  1. extrapyramidal symptoms

    assess the extrapyramidal symptoms

    Time frame: baseline, 4 weeks, 8 weeks

06

Study locations

1 of 1 sites recruiting
  • Beijing HuiLongGuan Hospital
    Beijing, Beijing 102208, China
    • Jingxu Chen · Contact · chenjx1110@163.com · 86-13681394260
    • Jingxu Chen · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT02013232
Lead sponsor
Beijing HuiLongGuan Hospital
Responsible party
Jingxu Chen (associate professor, Beijing HuiLongGuan Hospital) — Principal investigator
First posted
Dec 17, 2013
Start date
Feb 2013
Primary completion
Jan 2014 (estimated)
Completion
Feb 2014 (estimated)
Last update
Dec 17, 2013

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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