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

NCT01742390 | Unknown Phase 4 DMC

• 1 other identifier: ARI_IIT_01/02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Sexual Dysfunction; Hyperprolactinemia

Keywords

schizophrenia; risperidone; paliperidone; aripiprazole

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (2)

Aripiprazole

EXPERIMENTAL

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

Drug: Aripiprazole

risperidone or paliperidone

ACTIVE COMPARATOR

Stay on risperidone (RIS) or paliperidone (PALI)

Drug: risperidone or paliperidone

Interventions

Aripiprazole DRUG

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

Aripiprazole

risperidone or paliperidone DRUG

risperidone or paliperidone

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• \) 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

Sponsors & Collaborators

• Si Tianmei: lead

Study Sites (2)

Institute of mental health, Peking University

Beijing, Beijing Municipality, 100191, China

NOT YET RECRUITING

The first hospital of Hebei Province University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Hyperprolactinemia; Schizophrenia

Interventions

Aripiprazole; Risperidone; Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines; Isoxazoles; Azoles

Central Study Contacts

Tianmei Si, MD.

CONTACT

861082801948; si.tian-mei@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: December 5, 2012
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: March 14, 2013

Record last verified: 2013-03

Locations

CN (2)