NCT00969930

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 16, 2011

Status Verified

September 1, 2009

Enrollment Period

1.6 years

First QC Date

September 1, 2009

Last Update Submit

August 15, 2011

Conditions

Bipolar

Keywords

COMTApoEBDNFexecutive functionbipolarcognitionCognitive deficits and Bipolar disease type I

Outcome Measures

Primary Outcomes (1)

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

    18 months

Study Arms (2)

healthy controls

BD type I patients

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young bipolar disease patients in mania, depression, hypomania or mixed states without medication use over the past 15 days.

You may qualify if:

  • BD type 1
  • non euthymia
  • y.o.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry, School of Medicine University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 20406267DERIVED

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

August 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

August 16, 2011

Record last verified: 2009-09

Locations

BR(1)