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Clinical Trials/DRKS00004316
DRKS00004316
Recruiting
Phase 2

Improvement of cognitive function in bipolar disorder by aripiprazole adjunct treatment - CIBA

Bristol-Myers Squibb GmbH & Co. KGaA 0 sites52 target enrollmentSeptember 6, 2012
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ConditionsF31.7Bipolar affective disorder, currently in remission

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
F31.7
Sponsor
Bristol-Myers Squibb GmbH & Co. KGaA
Enrollment
52
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 6, 2012
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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Cognitive impairment in bipolar disorder treated with aripiprazole (memory, alertness, etc.)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.
EUCTR2009-017581-22-DEDepartment of Psychiatry and Psychotherapy, Charity University Medicine