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Status unknownNCT00969930LicavalgeneUpdated Aug 16, 2011

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

An observational study in Bipolar, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-16.

Sponsored by University of Sao Paulo · Observational

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 35 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Bipolar

Keywords

  • COMT
  • ApoE
  • BDNF
  • executive function
  • bipolar
  • cognition
  • Cognitive deficits and Bipolar disease type I
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In context

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • organic disease
  • use of drugs
  • schizophrenia
  • mental retardation
  • illiterate
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)

Groups and cohorts

  • healthy controls
  • BD type I patients
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What researchers measure

Primary outcomes

  1. Cognitive deficits in BD patients are associated with COMT, ApoE and BDNF polymorphisms

    Time frame: 18 months

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Study locations

1 site
  • Institute of Psychiatry, School of Medicine University of Sao Paulo
    Sao Paulo, Brazil
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References and documents

Publications

  • Soeira-de-Souza MG, Bio DS, Dias VV, Martins do Prado C, Campos RN, Costa LF, Moreno DH, Ojopi EB, Gattaz WF, Moreno RA. SHORT COMMUNICATION: Apolipoprotein E genotype and cognition in bipolar disorder. CNS Neurosci Ther. 2010 Oct;16(5):316-21. doi: 10.1111/j.1755-5949.2010.00153.x. Erratum In: CNS Neurosci Ther. 2010 Dec;16(6):380. Soeiro de Souza, Marcio Gerhardt [corrected to Soeira-de-Souza, Marcio Gerhardt]. PubMed 20406267 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00969930
Lead sponsor
University of Sao Paulo
First posted
Sep 2, 2009
Start date
Aug 2009
Primary completion
Mar 2011
Completion
Mar 2012 (estimated)
Last update
Aug 16, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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