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

Recruitment & Eligibility

Inclusion Criteria

Age: 12-55 years (male), 12-40 (female)
Diagnosis: Schizophrenia spectrum disorders & bipolar spectrum disorders (only Korea) by DSM-IV-TR
Receiving RIS or PALI with stable dose for > 1 month by their physician;
Prolactin level Adult: > 20 ng/ml (male), 25 ng/ml (female) Child/Adolescent: > 20 ng/ml (male, female)
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.
Subjects who have consented to participate by signing an informed consent form.

Exclusion Criteria

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)
History of hematological and/or solid malignancies
Physical or functional obstruction to food intake or impaired digestive/absorptive function
Known hypersensitivity to any study medication (risperidone, paliperidone, and aripiprazole)
Insulin requiring diabetes mellitus or poorly controlled diabetes mellitus (HbA1c > 9% or change of antidiabetics treatment within the 12weeks prior to screening)
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.)
Baseline QTc interval of > 450 msec
Hepatic and/or renal dysfunction

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Aripiprazole	Aripiprazole	Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
risperidone or paliperidone	risperidone or paliperidone	Stay on risperidone (RIS) or paliperidone (PALI)

Primary Outcome Measures

Name	Time	Method
Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks	12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of absence of sexual/reproductive system dysfunction on the UKU side effect rating scale or ASEX	12 weeks

Recruitment & Eligibility