Cognitive impairment in bipolar disorder treated with aripiprazole (memory, alertness, etc.)
- Conditions
- 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.
- Registration Number
- EUCTR2009-017581-22-DE
- Lead Sponsor
- Department of Psychiatry and Psychotherapy, Charity University Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Axis 1 condition other than bipolar disorder during last 6 month
organic brain disorder
pregnancy or breast feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To improve baseline cognitive functioning regarding verbal memory by 12 weeks aripiprazole add-on therapy in bipolar, euthymic patients.<br><br>;Secondary Objective: Secondary endpoints are the changes in cognitive functioning in the following domains: <br><br>1.working memory <br><br>2.executive functioning <br><br>3.attention<br>;Primary end point(s): Primary endpoint is change in verbal memory function measured with California Verbal Learning Test (CVLT).
- Secondary Outcome Measures
Name Time Method