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Genetic Association Study Between GAD1 and Reelin Polymorphisms and GABA/Glutamate MRS in Bipolar Disorder Type 1 and Healthy Controls: SPECGENE PROJECT (SPECGENE)

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ClinicalTrials.gov Identifier: NCT01237158
Recruitment Status : Unknown
Verified October 2010 by University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : November 9, 2010
Last Update Posted : August 16, 2011
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo

Brief Summary:

Background: The pathophysiological mechanisms of bipolar disorder are not completely clarified and several hypothesis have already been formulated including the role of monoamines, gama amino butyric acid (GABA) and glutamate. GABA is the main inhibitory neurotransmitter while glutamate is the main excitatory neurotransmitter. Genes that play a role in GABA metabolism and in the activity of GABA neurons are very important to understand the GABA function, once they affect neurodevelopment and its dysfunctions may predispose to neuropsychiatric diseases. The two genes that are going to be study in this project are glutamic acid decarboxylase (GAD1) and reelin (Reln). The enzyme glutamic acid descarboxylase (GAD67) metabolizes glutamate in GABA in the pre synaptic neuronal regions and is coded by the gene GAD1. Reelin is secretory serine protease with dual roles in mammalian brain: embryologically, it guides neurons and radial glial cells to their corrected positions in the developing brain; in adult brain, Reelin is involved in a signaling pathway which underlies neurotransmission, memory formation and synaptic plasticity. Magnetic resonance spectroscopy (MRS) studies on bipolar disorder show a number of alterations in cerebral level of GABA and glutamate in different cerebral areas when compared to healthy subjects and other mood disorders. Objective: Investigate in bipolar patients and healthy controls the association of GAD1 and Reln single nucleotide polymorphisms(SNP) and cerebral levels of GABA/glutamate on MRS. Methods: 70 symptomatic bipolar I patients medication free and 70 healthy controls are going to be genotyped for GAD1 and Reln SNPs and GABA/glutamate MRS.

Key words: GAD1, GAD67, bipolar, GABA, Glutamate, Reelin, Rln, Spectroscopy.


Condition or disease
Bipolar Disorder

Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genetic Association Study Between GAD1 and Reelin Polymorphisms and GABA/Glutamate MRS in Bipolar Disorder Type 1 and Healthy Controls: SPECGENE PROJECT
Study Start Date : October 2010
Estimated Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Group/Cohort
healthy controls
bipolar disorder type I



Primary Outcome Measures :
  1. association between GABA/glutamate brain levels and GAD1 polymorphisms [ Time Frame: single evaluation ]

Secondary Outcome Measures :
  1. association between GABA/glutamate brain levels and Reelin polymorphisms [ Time Frame: single evaluation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Bipolar Disorder Patients
Criteria

Inclusion Criteria:

  • Bipolar disorder type I diagnose (DSM-IV criteria)
  • Medication free (4 last weeks)

Exclusion Criteria:

  • heavy smokers
  • cannabis use
  • recent alcohol abuse (14 days)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237158


Contacts
Contact: Marcio G Soeiro-de-Souza, MD mgss@usp.br

Locations
Brazil
Institute of Psychiatry HCFMUSP Recruiting
Sao Paulo, Brazil
Contact: Marcio G Soeiro-de-Souza, MD       mgss@usp.br   
Principal Investigator: Marcio G Soeiro-de-Souza, MD         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ricardo Alberto Moreno, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01237158     History of Changes
Other Study ID Numbers: nov 2010
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: October 2010

Keywords provided by University of Sao Paulo:
GAD1,
GAD67,
bipolar,
GABA,
Glutamate,
Reelin,
Rln,
Spectroscopy
euthymic bipolar I patients

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders