Improvement of cognitive function in bipolar disorder by aripiprazole adjunct treatment

Phase 2

Recruiting

Conditions: F31.7
Bipolar affective disorder, currently in remission

Registration Number: DRKS00004316

Lead Sponsor: Bristol-Myers Squibb GmbH & Co. KGaA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 52

Inclusion Criteria

Bipolar Disorder (BP I + BP II)
Euthymic mood state since 6 months at least
No significant affective symptomatology measured by Hamilton Rating Depression Scale < 10 and Young Mania
Rating Scale < 12
Stable medication with mood stabilizers and antidepressants
Age : Patients from 18 to 70 years.
Cognitive Impairment measured on three self reporting questionnaires (FEDA, CSS, CFQ)
In women: negative pregnancy test
Written, informed consent
No participation in any other clinical trial 1 months before entry and druing the study

Exclusion Criteria

Current Psychotic symptoms
pregnancy or breast feeding
contraindication for treatment with aripiprazole, e.g. known hypersensitivity to the active substance or additives
pretreatment with aripiprazole during the last 3 months before enrolment
diagnosis of dementia or organic brain disorder
diagnosis of substance dependency during the last 6 months before enrolment (except nicotine and caffeine)
diagnosis of antisocial personality disorder
hospitalization because of juridical order
MRI contraindication

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To improve baseline cognitive functioning regarding verbal memory by add-on therapy, which is investigated by California Verbal Learning Test (CVLT) at week 1 and 12. <br><br>Primary endpoint for the effectiveness of a Aripiprazol Addon therapy is a differential activation in regions such as the dorsolateral prefrontal cortex and the parietal cortex in the N-Back-Task concerning working memory using functional magnet resonance imaging (fMRI). Therefore two groups are compared: one group before Aripiprazol therapy and one group after a 12 week Aripiprazol therapy.

Secondary Outcome Measures