A 16-Week, Multicenter, Randomized, Open-label Study to Assess the Effects ofAripiprazole versus other Atypical Antipsychotics in the Treatment of SchizophrenicPatients with Metabolic SyndromeEstudio abierto, aleatorizado, multicéntrico, de 16 semanas de duración, para evaluar los efectos de aripiprazol frente a otros antipsicóticos atípicos en el tratamiento de pacientes esquizofrénicos con Síndrome Metabólico”
- Conditions
- Subjects with schizophrenia who developed metabolic syndromePacientes con esquizofrenia que desarrollan síndrome metabólicoMedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia
- Registration Number
- EUCTR2007-001217-42-ES
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 632
1) Signed Written Informed Consent
a) Subjects must be competent to understand the nature of the study, sign the
informed consent, agree to comply with prescribed dosage regimens, report for
regularly scheduled visits with their caring physician, able to provide reliable
information for safety, efficacy and Quality of Life assessments and communicate
to the psychiatrist about adverse events and concomitant medication use;
b) The informed consent process must be documented by signing the informed
consent form prior to any study-related procedures including alterations in
medications in preparation for study entry and subject’s assignment via IVRS.
2) Target Population
a) Subjects with a diagnosis of schizophrenia as defined by DSM-IV-TR criteria
b) Subjects who have been on antipsychotic treatment for at least 6 months, limited
to oral olanzapine, risperidone and quetiapine within the dose range specified in
their respective SmPCs;
c) Subjects with a confirmed diagnosis of metabolic syndrome, confirmed as the
presence of at least 3 out of the 5 following criteria (ATP-III A criteria13):
i) Waist: > 102 cm in males; > 88 cm in females;
ii) Blood Pressure: systolic BP = 130 or diastolic BP = 85 mm Hg;
iii) Fasting HDL: < 40 mg/dL in males; < 50 mg/dL in females [< 1.04 mmol/L in
males; < 1.30 mmol/L in females];
iv) Fasting Triglycerides: = 150 mg/dL [= 1.70 mmol/L];
v) Fasting Glucose: = 100 mg/dL [= 5.55 mmol/L].
d) Subjects not being treated specifically for any of the parameters related to
metabolic syndrome at the time of randomization;
e) Subjects with a CGI-S score = 4 at baseline;
f) Subjects for whom it is clinically appropriate to switch from their current atypical
antipsychotic to aripiprazole, as determined by the Investigator.
3) Age and Sex
Men and women, ages = 18 to = 65 years.
Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable method to avoid
pregnancy for the entire study period and for up to 4 weeks after the last dose of
investigational product.
b) WOCBP using a prohibited contraceptive method. No specific contraceptive methods are prohibited in this study. Women practicing abstinence should use a
reliable method of contraception (except birth control pills) if they choose to become sexually active during the study.
c) Women who are pregnant or breastfeeding.
d) Women with a positive pregnancy test on enrollment or prior to investigational
product administration.
e) Sexually active fertile men not using effective birth control if their partners are
WOCBP.
2) Target Disease Exceptions
a) Subjects who are at risk for committing suicide: either having active suicidal
ideation considered clinically significant by the Investigator or recently attempted
suicide;
b) Subjects who have met DSM-IV-TR criteria for any significant Psychoactive
Substance Use Disorder within 3 months prior to Screening.
3) Medical History and Concurrent Diseases
a) Subjects with a current diagnosis of type-1 or type-2 diabetes mellitus;
b) Subjects with a diagnosis of schizoaffective disorder, bipolar disorder, depression
with psychotic symptoms, or organic brain syndromes;
c) Subjects with a history of neuroleptic malignant syndrome;
d) Subjects with any of the following neurological diagnosis: Parkinson’s disease,
Alzheimer’s disease, multiple sclerosis, cerebral palsy, mental retardation;
e) Subjects with epilepsy, a history of seizures (except for a single childhood febrile
seizure), a history of stroke or who have a history or evidence of other medical
conditions that would expose them to an undue risk of a significant adverse event
or interfere with assessments of safety or efficacy during the course of the trial.
4) Physical and Laboratory Test Findings
a) The following laboratory test results are exclusionary:
i) Platelets < 75,000 / mm³ [or < 75 x 10E9 c/L]
ii) Hemoglobin < 9 g/dL [or < 90 g/L]
iii) Absolute Neutrophil Count (ANC) = 1000/mm3 [or = 1.0 x 10E9 c/L]
iv) AST (SGOT) or ALT (SGPT) > 3x upper limit of normal
v) Creatinine > 2 mg/dL [or > 177 µmol/L]
vi) Fasting glucose = 126 mg/dL [= 6.99 mmol/L]
b) The following ECG finding is exclusionary: QTc > 475 msec
c) Subjects with detectable levels of cocaine in the drug screen. Subjects with a
positive drug screen for stimulants or other drugs of abuse that in the
investigator's judgment are considered to be abuse or dependence;
d) Blood alcohol level = 50 mg/dL [or = 10.9 mmol/L]
In addition, subjects should be excluded if they have any other abnormal laboratory
test result, vital sign result or ECG finding that in the investigator’s judgment is
medically significant, in that it would impact the safety of the subject or the
interpretation of the study results.
5) Allergies and Adverse Drug Reactions
a) Subjects who are known to be allergic or hypersensitive to aripiprazole
(Abilify™) or other dihydrocarbostyrils;
b) Subjects with history of hypersensitivity to antipsychotic agents.
6) Prohibited Treatments and/or Therapies
a) Subjects currently being treated for one of the parameters of metabolic syndrome;
b) Subjects who are likely to require prohibited concomitant therapy during the trial;
c) Subjects who have previously received study medication in an aripiprazole
clinical study or who participated in any clinical study with an inve
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method