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
NCT ID: NCT01742390
Last Updated: 2013-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2013-02-28
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aripiprazole
Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
Aripiprazole
Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
risperidone or paliperidone
Stay on risperidone (RIS) or paliperidone (PALI)
risperidone or paliperidone
Interventions
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Aripiprazole
Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
risperidone or paliperidone
Eligibility Criteria
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Inclusion Criteria
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
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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12 Years
55 Years
ALL
No
Sponsors
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Si Tianmei
OTHER
Responsible Party
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Si Tianmei
Professor
Locations
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Institute of mental health, Peking University
Beijing, Beijing Municipality, China
The first hospital of Hebei Province University
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Xueyi Wang, Professor
Role: primary
Other Identifiers
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ARI_IIT_01/02
Identifier Type: -
Identifier Source: org_study_id
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