Brain Voxel-based Morphometry in Bipolar Mania

NCT03181698 | Completed

• 1 other identifier: VBM MANIA
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Bipolar disorder is a complex psychiatric disorder characterized by recurrent episodes of mania or hypomania and depression, and affects around one to three percent of the population . Bipolar Disorder is associated with significant psychosocial morbidity and mortality , and is among the leading causes of disability worldwide . The disease is highly heritable, but the underlying pathophysiology is not yet understood .

Conditions

Brain Voxel-based Morphometry in Mania

Outcome Measures

Primary Outcomes (1)

• mean differences in measurements of different brain structures

  mean differences in measurements of brain structures between patients of Mania and Healthy controls by using standard of all statistical parametric brain mapping-based processing software.voxels typically represent a volume of 27 mm3 (a cube with 3mm length sides)

  2 hours

Study Arms (2)

first group

patients with more than one episodes of mania

Diagnostic Test: Magnetic resonance imaging

second group

sex-matched and age- matched healthy controls

Diagnostic Test: Magnetic resonance imaging

Interventions

Magnetic resonance imaging DIAGNOSTIC_TEST

A full Magnetic Resonance Imaging examination of the brain will be done for each of the subjects included in the study. The protocol of the study will include a high-resolution thin-cuts three Dimensions-T1 weighted gradient echo sequence to be used for the morphometric study. The obtained images will be analyzed for any gross structural abnormalities. by using fully-automated computational voxel-based volumetric software that calculates the volume of different structures of the brain. The obtained data will be analyzed statistically using linear regression tests to determine the differences between Bipolar Disorder type I mania patients and the healthy controls

first group; second group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed to have mood disorder Bipolar I mania with or without psychotic features according to criteria of Diagnostic and Statistical Manual of Mental disorders-IV by psychiatric sheath of psychiatric unit at Assiut University hospital . and sex and age-matched healthy subjects

You may qualify if:

• clinically diagnosed to have mood disorder Bipolar I mania with or without psychotic features according to criteria of Diagnostic and Statistical Manual of Mental disorders-IV by psychiatric sheath of psychiatric unit at Assiut University hospital .

You may not qualify if:

• first and second degree relatives of psychiatric patients will be excluded from the healthy controls.
• Persons with any neurological disorder or other psychiatric illness will be excluded from controls
• Patients with proven major structural abnormality as detected during Magnetic Resonance Imaging examination will be excluded from patients or healthy controls.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (7)

• Hibar DP, Westlye LT, van Erp TG, Rasmussen J, Leonardo CD, Faskowitz J, Haukvik UK, Hartberg CB, Doan NT, Agartz I, Dale AM, Gruber O, Kramer B, Trost S, Liberg B, Abe C, Ekman CJ, Ingvar M, Landen M, Fears SC, Freimer NB, Bearden CE; Costa Rica/Colombia Consortium for Genetic Investigation of Bipolar Endophenotypes; Sprooten E, Glahn DC, Pearlson GD, Emsell L, Kenney J, Scanlon C, McDonald C, Cannon DM, Almeida J, Versace A, Caseras X, Lawrence NS, Phillips ML, Dima D, Delvecchio G, Frangou S, Satterthwaite TD, Wolf D, Houenou J, Henry C, Malt UF, Boen E, Elvsashagen T, Young AH, Lloyd AJ, Goodwin GM, Mackay CE, Bourne C, Bilderbeck A, Abramovic L, Boks MP, van Haren NE, Ophoff RA, Kahn RS, Bauer M, Pfennig A, Alda M, Hajek T, Mwangi B, Soares JC, Nickson T, Dimitrova R, Sussmann JE, Hagenaars S, Whalley HC, McIntosh AM, Thompson PM, Andreassen OA. Subcortical volumetric abnormalities in bipolar disorder. Mol Psychiatry. 2016 Dec;21(12):1710-1716. doi: 10.1038/mp.2015.227. Epub 2016 Feb 9.

  PMID: 26857596 BACKGROUND

• Angst F, Stassen HH, Clayton PJ, Angst J. Mortality of patients with mood disorders: follow-up over 34-38 years. J Affect Disord. 2002 Apr;68(2-3):167-81. doi: 10.1016/s0165-0327(01)00377-9.

  PMID: 12063145 BACKGROUND

• Tondo L, Isacsson G, Baldessarini R. Suicidal behaviour in bipolar disorder: risk and prevention. CNS Drugs. 2003;17(7):491-511. doi: 10.2165/00023210-200317070-00003.

  PMID: 12751919 BACKGROUND

• Rocha-Rego V, Jogia J, Marquand AF, Mourao-Miranda J, Simmons A, Frangou S. Examination of the predictive value of structural magnetic resonance scans in bipolar disorder: a pattern classification approach. Psychol Med. 2014 Feb;44(3):519-32. doi: 10.1017/S0033291713001013. Epub 2013 Jun 5.

  PMID: 23734914 BACKGROUND

• Soares JC, Mann JJ. The anatomy of mood disorders--review of structural neuroimaging studies. Biol Psychiatry. 1997 Jan 1;41(1):86-106. doi: 10.1016/s0006-3223(96)00006-6.

  PMID: 8988799 BACKGROUND

• Lipska BK, Jaskiw GE, Weinberger DR. Postpubertal emergence of hyperresponsiveness to stress and to amphetamine after neonatal excitotoxic hippocampal damage: a potential animal model of schizophrenia. Neuropsychopharmacology. 1993 Aug;9(1):67-75. doi: 10.1038/npp.1993.44.

  PMID: 8397725 BACKGROUND

• Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.

  PMID: 1695401 BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 9, 2017
• Study Start: September 22, 2017
• Primary Completion: July 14, 2018
• Study Completion: September 11, 2018
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)