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

Si Tianmei (Other)
Overall Status
Unknown status
CT.gov ID

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
Phase 4

Study Design

Study Type:
Anticipated Enrollment :
120 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria


Ages Eligible for Study:
12 Years to 55 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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: 1217 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: 1855 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

Contacts and Locations


Site City State Country Postal Code
1 Institute of mental health, Peking University Beijing Beijing China 100191
2 The first hospital of Hebei Province University Shijiazhuang Hebei China 050000

Sponsors and Collaborators

  • Si Tianmei


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Si Tianmei, Professor, Peking University
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • ARI_IIT_01/02
First Posted:
Dec 5, 2012
Last Update Posted:
Mar 14, 2013
Last Verified:
Mar 1, 2013
Keywords provided by Si Tianmei, Professor, Peking University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2013