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

Bipolar Clinical Trial

— Licavalgene  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00969930
• Other study ID #: LICAVALGENE 2009
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 1, 2009
• Last updated: August 15, 2011
• Start date: August 2009
• Est. completion date: March 2012

Study information

• Verified date: September 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• BD type 1

• non euthymia

• 18-35 y.o.

Exclusion Criteria:

• pregnancy

• organic disease

• use of drugs

• schizophrenia

• mental retardation

• illiterate

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar

Locations

Country	Name	City	State
Brazil	Institute of Psychiatry, School of Medicine University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive deficits in BD patients are associated with COMT, ApoE and BDNF polymorphisms		18 months	No