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Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE (Licavalgene)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by University of Sao Paulo.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00969930
First Posted: September 2, 2009
Last Update Posted: August 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose
This is a genetic association study of cognitive impairment in young bipolar disease type I patients without medications in mania, depression, hypomania or mixed states.

Condition
Bipolar

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Cognitive deficits in BD patients are associated with COMT, ApoE and BDNF polymorphisms [ Time Frame: 18 months ]

Estimated Enrollment: 80
Study Start Date: August 2009
Estimated Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy controls
BD type I patients

Detailed Description:

Introduction:

Cognitive impairment in bipolar disease (BD) patients is common and recent data suggests that it may be an endophenotype of the disease as it differs individually, persists during periods of euthymia and co segregates in families of BD patients. Cognition is a complex trait and is therefore likely to be underpinned by many genes, each with a relatively small effect. Performance in each domain of the neuropsychological assessment can be statistically linked to the functional activity of particular protein and by extension to the genetic variants accounting for theses functional differences.

Methods:

80 patients with BD type I (SCID DSM-IV), age from 18 to 35 years old, currently on mania, depression, hypomania or mixed state after medication wash out will be submitted to complete neuropsychological evaluation and genotyped for COMT (val158met, rs165599, -287, rs737865), ApoE (epsilon 4) and BDNF (val66met)and 80 healthy controls.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young bipolar disease patients in mania, depression, hypomania or mixed states without medication use over the past 15 days.
Criteria

Inclusion Criteria:

  • BD type 1
  • non euthymia
  • 18-35 y.o.

Exclusion Criteria:

  • pregnancy
  • organic disease
  • use of drugs
  • schizophrenia
  • mental retardation
  • illiterate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969930


Locations
Brazil
Institute of Psychiatry, School of Medicine University of Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ricardo Alberto Moreno, Institute of Psychiatry, Mood Disorders Unit, School of Medicine, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00969930     History of Changes
Other Study ID Numbers: LICAVALGENE 2009
First Submitted: September 1, 2009
First Posted: September 2, 2009
Last Update Posted: August 16, 2011
Last Verified: September 2009

Keywords provided by University of Sao Paulo:
COMT
ApoE
BDNF
executive function
bipolar
cognition
Cognitive deficits and Bipolar disease type I