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

Sponsor

Si Tianmei (Other)

Overall Status

Unknown status

CT.gov ID

NCT01742390

Collaborator

(none)

120

Enrollment

Locations

Arms

15.9

Duration (Months)

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks [12 weeks]

Secondary Outcome Measures

Percentage of absence of sexual/reproductive system dysfunction on the UKU side effect rating scale or ASEX [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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