Phase
Condition
Diabetes Prevention
Schizophrenia And Schizoaffective Disorders (Pediatric)
Tourette's Syndrome
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Competency in understanding nature of study and ability to sign informed consent form
A clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder (manic or mixed) that has been treated with antipsychotics (oral olanzapine,risperidone or quetiapine) for at least 3 months.
Treatment with any of the antipsychotic medications olanzapine, risperidone, orquetiapine for at least 3 months
A Clinical Global Impression-Severity Scale score of 4 or lower at baseline
Confirmed diagnosis of metabolic syndrome
Patients not receiving treatment specifically for any of the parameters related tometabolic syndrome at the time of randomization
Women of childbearing potential must be using an adequate method of contraception toavoid pregnancy throughout the study and up to 4 weeks after last dose ofinvestigational product
Patients for whom it is clinically appropriate to switch from their current atypicalantipsychotic to aripiprazole (determined by the investigator)
Exclusion
Exclusion Criteria:
Risk of suicide (suicidal ideation or recently attempted suicide)
Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revisioncriteria for any significant psychoactive substance use disorder within 3 months ofscreening
Diagnosis of type 1 or 2 diabetes mellitus
Current treatment for 1 of the components of metabolic syndrome
Use of medication for the purpose of weight loss
Diagnosis of bipolar disorders other than bipolar 1, depression with psychoticsymptoms, or organic brain syndromes
History of neuroleptic malignant syndrome
Diagnosis of Parkinson's disease, Alzheimer's disease, multiple sclerosis, cerebralpalsy, epilepsy, or mental retardation
History of seizures
Abnormal blood count for platelets, hemoglobin, absolute neutrophils, aspartateaminotransferase, alanine aminotransferase, creatinine, fasting glucose, andthyroid-stimulating hormone
Electrocardiogram recording with QTc interval >475 msec
Detectable levels of cocaine or positive screen for stimulants or other drugsconsidered (determined by the investigator) to be of abuse or dependence
Blood alcohol levels superior or equal to 50 mg/dL [or 10.9 mmol/L]
Prior participation in an aripiprazole clinical trial
Treatment with aripiprazole within 1 month of enrollment
Predefined exclusionary laboratory tests
Patients with Bipolar Disorder treated with adjunctive therapy other than a stabledose of mood stabilizers (lithium or valproate) must undergo a 30-day washout periodfor adjunctive therapies, such as antidepressants, prior to randomization.
Study Design
Connect with a study center
Local Institution
Calgary, Alberta T2N 2T9
CanadaSite Not Available
Local Institution
Pentincton, British Columbia V2A 4M4
CanadaSite Not Available
Local Institution
Vancouver, British Columbia V6T 2A1
CanadaSite Not Available
Local Institution
Hamilton, Ontario L8N 3K7
CanadaSite Not Available
Local Institution
London, Ontario N6H 4V1
CanadaSite Not Available
Local Institution
Markham, Ontario L6B 1A1
CanadaSite Not Available
Local Institution
Mississauga, Ontario L5M 4N4
CanadaSite Not Available
Local Institution
Toronto, Ontario M5T 2S8
CanadaSite Not Available
Local Institution
Montreal, Quebec H3M 3A9
CanadaSite Not Available
Local Institution
Quebec, G1R 2W8
CanadaSite Not Available

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