search
Back to results

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

Primary Purpose

Sexual Dysfunction, Hyperprolactinemia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aripiprazole
risperidone or paliperidone
Sponsored by
Si Tianmei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunction focused on measuring schizophrenia, risperidone, paliperidone, aripiprazole

Eligibility Criteria

12 Years - 55 Years (Child, Adult)All SexesDoes not accept 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: 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

-

Sites / Locations

  • Institute of mental health, Peking University
  • The first hospital of Hebei Province UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aripiprazole

risperidone or paliperidone

Arm Description

Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)

Stay on risperidone (RIS) or paliperidone (PALI)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 22, 2012
Last Updated
March 13, 2013
Sponsor
Si Tianmei
search

1. Study Identification

Unique Protocol Identification Number
NCT01742390
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Si Tianmei

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Hyperprolactinemia
Keywords
schizophrenia, risperidone, paliperidone, aripiprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
Arm Title
risperidone or paliperidone
Arm Type
Active Comparator
Arm Description
Stay on risperidone (RIS) or paliperidone (PALI)
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
Intervention Type
Drug
Intervention Name(s)
risperidone or paliperidone
Primary Outcome Measure Information:
Title
Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of absence of sexual/reproductive system dysfunction on the UKU side effect rating scale or ASEX
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tianmei Si, MD.
Phone
861082801948
Email
si.tian-mei@163.com
Facility Information:
Facility Name
Institute of mental health, Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianmei Si, MD.
Phone
8610-82801948
Email
si.tian-mei@163.cm
First Name & Middle Initial & Last Name & Degree
Tianmei Si, MD.
Facility Name
The first hospital of Hebei Province University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyi Wang, Professor
Phone
0311-85917290
First Name & Middle Initial & Last Name & Degree
Xueyi Wang

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs