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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT01520350
Eligibility Criteria:
Inclusion Criteria:
* Age : 18-65
* Male or female
* Bipolar Disorder type I
* Current depressive episode (with MADRS ≥ 20 and item 2 (reported sadness) ≥ 3) for a minimum of 2 weeks but ≤ 52 weeks at screening visit and baseline visit)
* If female and of childbearing potential, is using an adequate method of contraception.
* Is treated with a mood stabilizer (lithium and/or valproate)
* Patient is able to give his consent
Exclusion Criteria:
* Is at high risk of suicide as defined by a score of ≥ 3 to item 10 of MADRS and/or in the clinical opinion of the investigator
* Hypo(mania) episode with YMRS ≥ 8
* Psychotic symptoms as defined by a score of ≥ 4 to item 8 (content) of YMRS and/or in the opinion of the investigator
* Is treated with fluoxetine OR lamotrigine OR carbamazepine OR any antidepressants
* Is treated with risperidone OR olanzapine OR quetiapine OR ziprazidone OR any antipsychotics
* Is pregnant or lactating or absence of contraceptive treatment
* Drug abuse or dependence as per DSM-IV (MINI)
* Unstable medical condition
* Other psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, hyperthyroidism, diabetes, cardiac condition, hypertension
* Deficit in vitamin B12 or folate
* Alcohol or drug abuse
* Rapid cycling (more than 4 mood episodes per year)
* Active or history of difficulty to swallow
* Seizures not currently controlled with medications
* Orthostatic hypotension
* A history of clinically significant cardiovascular disorders and cardiac arrhythmias
* A low white blood cell count
* Known eye disease
* Involuntary, irregular muscle movements, especially in the face
* Known hypersensitivity to aripiprazole and any components of its formulation
* Known lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because ABILIFY tablets contain lactose
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01520350
Study Brief:
Protocol Section:
NCT01520350