Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2025-12-25 @ 4:37 AM
NCT ID:
NCT00857818
Eligibility Criteria:
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, or quetiapine 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 to metabolic syndrome at the time of randomization
* Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and up to 4 weeks after last dose of investigational product
* Patients for whom it is clinically appropriate to switch from their current atypical antipsychotic to aripiprazole (determined by the investigator)
Exclusion Criteria:
* Risk of suicide (suicidal ideation or recently attempted suicide)
* Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision criteria for any significant psychoactive substance use disorder within 3 months of screening
* 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 psychotic symptoms, or organic brain syndromes
* History of neuroleptic malignant syndrome
* Diagnosis of Parkinson's disease, Alzheimer's disease, multiple sclerosis, cerebral palsy, epilepsy, or mental retardation
* History of seizures
* Abnormal blood count for platelets, hemoglobin, absolute neutrophils, aspartate aminotransferase, alanine aminotransferase, creatinine, fasting glucose, and thyroid-stimulating hormone
* Electrocardiogram recording with QTc interval \>475 msec
* Detectable levels of cocaine or positive screen for stimulants or other drugs considered (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 stable dose of mood stabilizers (lithium or valproate) must undergo a 30-day washout period for adjunctive therapies, such as antidepressants, prior to randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00857818
Study Brief:
Protocol Section:
NCT00857818