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

Sexual Dysfunction Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01742390
• Other study ID #: ARI_IIT_01/02
• Status: Recruiting
• Phase: Phase 4
• First received: November 22, 2012
• Last updated: March 13, 2013
• Start date: February 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2013
• Source: Peking University
• Contact: Tianmei Si, MD.
• Phone: 861082801948
• Email: si.tian-mei[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 55 Years

Eligibility

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.

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

Study Design

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

Related Conditions & MeSH terms

• Hyperprolactinemia
• Sexual Dysfunction

Intervention

Drug:
• Aripiprazole
Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
• risperidone or paliperidone

Locations

Country	Name	City	State
China	Institute of mental health, Peking University	Beijing	Beijing
China	The first hospital of Hebei Province University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Si Tianmei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks		12 weeks	No
Secondary	Percentage of absence of sexual/reproductive system dysfunction on the UKU side effect rating scale or ASEX		12 weeks	No