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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Peking University
Sponsor:
Information provided by (Responsible Party):
Si Tianmei, Peking University
ClinicalTrials.gov Identifier:
NCT01742390
First received: November 22, 2012
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunction
Hyperprolactinemia
Drug: Aripiprazole
Drug: risperidone or paliperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of absence of sexual/reproductive system dysfunction on the UKU side effect rating scale or ASEX [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole
Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
Drug: Aripiprazole
Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
Active Comparator: risperidone or paliperidone
Stay on risperidone (RIS) or paliperidone (PALI)
Drug: risperidone or paliperidone

  Eligibility

Ages Eligible for Study:   12 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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  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: NCT01742390

Contacts
Contact: Tianmei Si, MD. 861082801948 si.tian-mei@163.com

Locations
China, Beijing
Institute of mental health, Peking University Not yet recruiting
Beijing, Beijing, China, 100191
Contact: Tianmei Si, MD.    8610-82801948    si.tian-mei@163.cm   
Principal Investigator: Tianmei Si, MD.         
China, Hebei
The first hospital of Hebei Province University Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Xueyi Wang, Professor    0311-85917290      
Sub-Investigator: Xueyi Wang         
Sponsors and Collaborators
Si Tianmei
  More Information

No publications provided

Responsible Party: Si Tianmei, Professor, Peking University
ClinicalTrials.gov Identifier: NCT01742390     History of Changes
Other Study ID Numbers: ARI_IIT_01/02
Study First Received: November 22, 2012
Last Updated: March 13, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
schizophrenia
risperidone
paliperidone
aripiprazole

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
9-hydroxy-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 August 20, 2014