BipolarLicavalgeneNCT00969930
Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE
An observational study of Bipolar, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young bipolar disease patients in mania, depression, hypomania or mixed states without medication use over the past 15 days.
Who may be able to join
- BD type 1
- non euthymia
- 18-35 y.o.
Who cannot join
- pregnancy
- organic disease
- use of drugs
- schizophrenia
- mental retardation
- illiterate
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Psychiatry, School of Medicine University of Sao Paulo
São Paulo, São Paulo
About this study
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.
- Conditions
- Bipolar
- Keywords
- COMT, ApoE, BDNF, executive function, bipolar, cognition, Cognitive deficits and Bipolar disease type I
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | Not described | |
| BD type I patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive deficits in BD patients are associated with COMT, ApoE and BDNF polymorphisms
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2011
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BipolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969930
- Sponsor's protocol ID
- LICAVALGENE 2009
- Acronym
- Licavalgene
- Status last verified
- Sep 2009
- First submitted
- 1 Sep 2009
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20406267
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE
- ClinicalTrials.gov ID
- NCT00969930
- Acronym / sponsor ID
- Licavalgene / LICAVALGENE 2009
- Conditions
- Bipolar
- Keywords
- COMT, ApoE, BDNF, executive function, bipolar, cognition, Cognitive deficits and Bipolar disease type I
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (estimated)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy controls | – | – |
| BD type I patients | – | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young bipolar disease patients in mania, depression, hypomania or mixed states without medication use over the past 15 days.
Key inclusion criteria (3 listed)
- BD type 1
- non euthymia
- 18-35 y.o.
Key exclusion criteria (6 listed)
- pregnancy
- organic disease
- use of drugs
- schizophrenia
- mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive deficits in BD patients are associated with COMT, ApoE and BDNF polymorphisms
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
- Derived from this study: PubMed 20406267Soeira-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive deficits in BD patients are associated with COMT, ApoE and BDNF polymorphisms (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00969930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011.