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:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00665366
Eligibility Criteria:
Key inclusion criteria:
* Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features
* Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole
* Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline
* Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment.
Key exclusion criteria:
* Women of childbearing potential 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
* A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder
* Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder)
* Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania
* Thyroid pathology
* Demonstrated cocaine abuse or dependence within the past 3 months prior to screening.
* History of neuroleptic malignant syndrome from antipsychotic agents
* Manic symptoms that investigator considers refractory to treatment
* Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms
* Significant risk of suicide based on history, mental status exam, or investigator judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00665366
Study Brief:
Protocol Section:
NCT00665366