Bipolar disorder is among the most severely debilitating diseases. Patients with bipolar disorder generally experience high rates of relapse, a chronic recurrent course, lingering residual symptoms, functional impairment, psychosocial disability and diminished well-being. More recent data have underlined the importance of neurocognitive impairments in the euthymic state including impairments in attention, memory and executive function.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Bipolar Disorder (BP I + BP II) Ethymic mood state since 6 months at least Stable medication with mood stabilizers Age > 18 y. Cognitive Impairment measured on self reporting questionnaires 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Axis 1 condition other than bipolar disorder during last 6 month organic brain disorder pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve baseline cognitive functioning regarding verbal memory by 12 weeks aripiprazole add-on therapy in bipolar, euthymic patients. ;Secondary Objective: Secondary endpoints are the changes in cognitive functioning in the following domains: 1. working memory 2. executive functioning 3. attention ;Primary end point(s): Primary endpoint is change in verbal memory function measured with California Verbal Learning Test (CVLT). | — |
Countries
Germany