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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00969930
First received: September 1, 2009
Last updated: August 15, 2011
Last verified: September 2009
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Sao Paulo

Additional 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
Study First Received: September 1, 2009
Last Updated: August 15, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on October 19, 2014