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

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 Overview

• Status: Unknown
• Conditions: Sexual Dysfunction; Hyperprolactinemia
• Intervention / Treatment: Drug: Aripiprazole; Drug: risperidone or paliperidone

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Not yet recruiting
      • Institute of Mental Health, Peking University
      • Contact: Tianmei Si, MD.; Phone Number: 8610-82801948; Email: si.tian-mei@163.cm
      • Principal Investigator: Tianmei Si, MD.
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The first hospital of Hebei Province University
      • Contact: Xueyi Wang, Professor; Phone Number: 0311-85917290
      • Sub-Investigator: Xueyi Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 51 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in severity of sexual/reproductive system dysfunction at 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of absence of sexual/reproductive system dysfunction on the UKU side effect rating scale or ASEX	12 weeks

Collaborators and Investigators

• Sponsor: Si Tianmei

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: November 22, 2012
• First Submitted That Met QC Criteria: December 2, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): March 14, 2013
• Last Update Submitted That Met QC Criteria: March 13, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: schizophrenia; risperidone; paliperidone; aripiprazole
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hypothalamic Diseases; Hyperpituitarism; Pituitary Diseases; Hyperprolactinemia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole; Paliperidone Palmitate; Risperidone
• Other Study ID Numbers: ARI_IIT_01/02