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A Multicenter Study to Evaluate the Effects of Switching to Aripiprazole 12 Weeks on the Sexual Dysfunction From Risperidone or Paliperidone in Patients With Schizophrenia Spectrum Disorders or Bipolar Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT01742390
Recruitment Status : Unknown
Verified March 2013 by Si Tianmei, Peking University.
Recruitment status was:  Recruiting
First Posted : December 5, 2012
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
Si Tianmei, Peking University

Tracking Information
First Submitted Date  ICMJE November 22, 2012
First Posted Date  ICMJE December 5, 2012
Last Update Posted Date March 14, 2013
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2012)
Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01742390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2012)
Percentage of absence of sexual/reproductive system dysfunction on the UKU side effect rating scale or ASEX [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Study to Evaluate the Effects of Switching to Aripiprazole 12 Weeks on the Sexual Dysfunction From Risperidone or Paliperidone in Patients With Schizophrenia Spectrum Disorders or Bipolar Spectrum Disorders
Official Title  ICMJE Not Provided
Brief Summary This trial designed to investigate the effect of switching to aripiprazole from risperidone or paliperidone on reverse prolactin level, and consequently improve sexual dysfunction in adult patients with schizophrenia spectrum disorders and bipolar spectrum disorders.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sexual Dysfunction
  • Hyperprolactinemia
Intervention  ICMJE
  • Drug: Aripiprazole
    Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
  • Drug: risperidone or paliperidone
Study Arms  ICMJE
  • Experimental: Aripiprazole
    Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
    Intervention: Drug: Aripiprazole
  • Active Comparator: risperidone or paliperidone
    Stay on risperidone (RIS) or paliperidone (PALI)
    Intervention: Drug: risperidone or paliperidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 2, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age: 12-55 years (male), 12-40 (female)
  2. Diagnosis: Schizophrenia spectrum disorders & bipolar spectrum disorders (only Korea) by DSM-IV-TR
  3. Receiving RIS or PALI with stable dose for > 1 month by their physician;
  4. Prolactin level Adult: > 20 ng/ml (male), 25 ng/ml (female) Child/Adolescent: > 20 ng/ml (male, female)
  5. Children and adolescents (age: 12~17 years) having more than one sexual system dysfunction measured by 5 of the 48 UKU items (galactorrhoea, gynecomastia and erectile dysfunction for male, galactorrhea, amenorrhoea/oligomenorrhoea, and dry vagina for female) or Adults (age: 18~55 years) who are considered to have sexual/reproductive dysfunction if they had either a total score of 19 or higher; a score of 5 or higher on one question; or a score of 4 or higher on 3 questions.
  6. Subjects who have consented to participate by signing an informed consent form.

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Exclusion Criteria:

  1. Medical disorder or psychiatric comorbidity or condition known to affect prolactin, sex hormone balance or bone metabolism (i.e., unstable medical disease, Cushing's disease, chronic renal failure, thyroid dysfunction, eating disorder)
  2. History of hematological and/or solid malignancies
  3. Physical or functional obstruction to food intake or impaired digestive/absorptive function
  4. Known hypersensitivity to any study medication (risperidone, paliperidone, and aripiprazole)
  5. Insulin requiring diabetes mellitus or poorly controlled diabetes mellitus (HbA1c > 9% or change of antidiabetics treatment within the 12weeks prior to screening)
  6. Uncontrolled hypertension (SBP/DBP 140/90 mmHg), congestive heart failure (NYHA class III or IV), other significant cardiovascular illness (myocardial infarction, unstable angina, cardiac arrhythmia etc.)
  7. Baseline QTc interval of > 450 msec
  8. Hepatic and/or renal dysfunction

1) Bilirubin level ≥ 1.5 upper normal limits 2) AST/ALT ≥ 3 UNL or 3) Serum creatinine ≥ 1.5 9. Any patient hospitalized for acute exacerbation of their condition within 2 months of randomization 10. Recent (within the past 1 month) or planned treatment with prohibited medications in the protocol

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01742390
Other Study ID Numbers  ICMJE ARI_IIT_01/02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Si Tianmei, Peking University
Study Sponsor  ICMJE Si Tianmei
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking University
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP