Voxel Based Morphometry In Patients With Psychotic Versus Non Psychotic Depression

NCT ID: NCT05034523

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

1. To examine structural brain changes in patients with depression measured using voxel based morphometry(VBM) in comparison with healthy subjects.
2. Relation between grey mater volume (GMV) and other structural changes, and the severity of clinical symptoms.
3. To study if there is structural brain difference between psychotic and non-psychotic depression

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Depression is a major psychiatric disorder and a leading cause of disability worldwide. The clinical representation encompasses affective, cognitive and somatic complains such as low mood, anxiety, lack of pleasure and interest, disturbances of sleep and appetite, decreased self-esteem, thoughts of guilt, hopelessness, and even suicide.

Major depressive disorder (MDD) with psychotic features (psychotic depression) is a severe disorder with a lifetime prevalence of 0.35-1% .

Over the last decades, increasing evidence from post-mortem studies and in vivo studies emerged that mood disorder can induce structural and morphometric changes of the brain The development of magnetic resonance imaging (MRI) has allowed for more advanced structural imaging

Several structural magnetic resonance imaging (s MRI) studies have identified key brain areas involved in MDD. In particular, voxel-based morphometry (VBM), it is helpful in quantitatively identifying unexpected anatomic changes studies have found that MDD is associated with widespread local brain abnormalities, mainly affecting the frontal gyrus, insula, temporal lobes and anterior cingulate gyrus . Structural white matter alterations have also been reported within the inferior parietal lobule and frontal gyrus .

Many studies are positive about grey matter (GM) volume reductions in various cortical regions in depressed patients compared to healthy controls . The most consistent findings appear to be related to GM loss in medial frontal cortex (MFC), anterior cingulate cortex (ACC) and orbitofrontal cortex (OFC) with less evidence about subcortical structures such as the amygdala and the hippocampus .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychotic Depression Non Psychotic Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI Voxel based morphometry

Voxel based morphometry through analysis of 3D T1 weighted sequence to assess total intracranial volume. All participants were scanned on the 1.5Tesla MR scanner (Achieva, Philips Medical Systems, Best, NL) with a 16-channel head coil at the diagnostic radiology department.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18-60 years old.
2. Based on DSM5 Criteria: MDD with or without psychotic features.

Exclusion Criteria

1 • Patients under 18 years old or above 60

2• Pregnant or lactating women.

3• Other current or past major psychiatric disorders

4• History or concurrent neurological disease(seizures) or prior head trauma with evidence of consequent cognitive impairment.

5• First degree family history of schizophrenia if the participant is less than 33 years old (mean age of onset of schizophrenia plus two standard deviations) to exclude possible prodromal phase of schizophrenia.

6• Unstable medical condition (i.e., any active illness that may affect the brain as blood dyscrasis, lymphomas, endocrinopathies, renal failure, chronic obstructive lung disease, systemic autoimmune disorders or Malignancy).

7• Patients being treated with steroids or hormonal therapy .

8• Current substances or alcohol use disorders (past diagnosis allowed if in remission for more than 6 months

9• Contraindications for MRI as:

* Metal implants or paramagnetic objects contained within the body (including heart pacemaker or surgical prosthesis)
* Claustrophobia significant enough to interfere with MRI

10• Refusal of informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Doaa Noor Eldin Abdelazeem Mohammed

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yasser Elserogy, MD

Role: STUDY_CHAIR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Doaa Elhefny, MSC

Role: CONTACT

+201022388263

Romany Jabra, MD

Role: CONTACT

References

Explore related publications, articles, or registry entries linked to this study.

Sacher J, Neumann J, Funfstuck T, Soliman A, Villringer A, Schroeter ML. Mapping the depressed brain: a meta-analysis of structural and functional alterations in major depressive disorder. J Affect Disord. 2012 Oct;140(2):142-8. doi: 10.1016/j.jad.2011.08.001. Epub 2011 Sep 3.

Reference Type BACKGROUND
PMID: 21890211 (View on PubMed)

Jaaskelainen E, Juola T, Korpela H, Lehtiniemi H, Nietola M, Korkeila J, Miettunen J. Epidemiology of psychotic depression - systematic review and meta-analysis. Psychol Med. 2018 Apr;48(6):905-918. doi: 10.1017/S0033291717002501. Epub 2017 Sep 12.

Reference Type BACKGROUND
PMID: 28893329 (View on PubMed)

Lui S, Zhou XJ, Sweeney JA, Gong Q. Psychoradiology: The Frontier of Neuroimaging in Psychiatry. Radiology. 2016 Nov;281(2):357-372. doi: 10.1148/radiol.2016152149.

Reference Type BACKGROUND
PMID: 27755933 (View on PubMed)

O'Connor S, Agius M. A systematic review of structural and functional MRI differences between psychotic and nonpsychotic depression. Psychiatr Danub. 2015 Sep;27 Suppl 1:S235-9.

Reference Type BACKGROUND
PMID: 26417770 (View on PubMed)

Schmaal L, Veltman DJ, van Erp TG, Samann PG, Frodl T, Jahanshad N, Loehrer E, Tiemeier H, Hofman A, Niessen WJ, Vernooij MW, Ikram MA, Wittfeld K, Grabe HJ, Block A, Hegenscheid K, Volzke H, Hoehn D, Czisch M, Lagopoulos J, Hatton SN, Hickie IB, Goya-Maldonado R, Kramer B, Gruber O, Couvy-Duchesne B, Renteria ME, Strike LT, Mills NT, de Zubicaray GI, McMahon KL, Medland SE, Martin NG, Gillespie NA, Wright MJ, Hall GB, MacQueen GM, Frey EM, Carballedo A, van Velzen LS, van Tol MJ, van der Wee NJ, Veer IM, Walter H, Schnell K, Schramm E, Normann C, Schoepf D, Konrad C, Zurowski B, Nickson T, McIntosh AM, Papmeyer M, Whalley HC, Sussmann JE, Godlewska BR, Cowen PJ, Fischer FH, Rose M, Penninx BW, Thompson PM, Hibar DP. Subcortical brain alterations in major depressive disorder: findings from the ENIGMA Major Depressive Disorder working group. Mol Psychiatry. 2016 Jun;21(6):806-12. doi: 10.1038/mp.2015.69. Epub 2015 Jun 30.

Reference Type BACKGROUND
PMID: 26122586 (View on PubMed)

Yuan Y, Zhang Z, Bai F, Yu H, You J, Shi Y, Qian Y, Liu W, Jiang T. Larger regional white matter volume is associated with executive function deficit in remitted geriatric depression: an optimized voxel-based morphometry study. J Affect Disord. 2009 May;115(1-2):225-9. doi: 10.1016/j.jad.2008.09.018. Epub 2008 Oct 21.

Reference Type BACKGROUND
PMID: 18945494 (View on PubMed)

Lai CH. Gray matter volume in major depressive disorder: a meta-analysis of voxel-based morphometry studies. Psychiatry Res. 2013 Jan 30;211(1):37-46. doi: 10.1016/j.pscychresns.2012.06.006. Epub 2012 Nov 10.

Reference Type BACKGROUND
PMID: 23146253 (View on PubMed)

Arnone D, Job D, Selvaraj S, Abe O, Amico F, Cheng Y, Colloby SJ, O'Brien JT, Frodl T, Gotlib IH, Ham BJ, Kim MJ, Koolschijn PC, Perico CA, Salvadore G, Thomas AJ, Van Tol MJ, van der Wee NJ, Veltman DJ, Wagner G, McIntosh AM. Computational meta-analysis of statistical parametric maps in major depression. Hum Brain Mapp. 2016 Apr;37(4):1393-404. doi: 10.1002/hbm.23108. Epub 2016 Feb 8.

Reference Type BACKGROUND
PMID: 26854015 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Voxel based MRI in depression

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Magnetoencephalography in Psychosis Program
NCT06978881 ENROLLING_BY_INVITATION