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

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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


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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Sexual Dysfunction

Intervention

Aripiprazole

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

120

Start Date

February 2013

Completion Date

June 2014

Primary Completion Date

December 2013

Eligibility Criteria

        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

        -
      

Gender

All

Ages

12 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

, 861082801948, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01742390

Organization ID

ARI_IIT_01/02


Responsible Party

Sponsor-Investigator

Study Sponsor

Si Tianmei


Study Sponsor

, , 


Verification Date

March 2013