NCT05034523

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

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

First Submitted

Initial submission to the registry

August 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 24, 2021

Last Update Submit

August 29, 2021

Conditions

Keywords

DepressionPsychotic depressionVoxel based morphometry

Outcome Measures

Primary Outcomes (2)

  • Study the structural brain changes in different areas in patients with psychotic depression and non-psychotic depression.

    Investigators will use MRI the voxel based morphometry to measure the volume of different areas in grey and white matter in depressed patients and compare them to structure of brain in healthy group.

    one year

  • Examine different variables related to major depressive disorder and their specific relation to structural changes in different areas in brain

    Investigators will measure the changes occur in volume of different areas in brain with different types of depression. Investigators will measure the changes in volume of different areas in brain which occur by the effect of psychotic features. Investigators will measure the effect of suicide on changes of volume of different areas of brain.

    one year

Interventions

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study included two groups: Group (A): patients' group diagnosed with major depressive disorder (MDD) which include (44) patients aged 18-60 years' old who attended psychiatric outpatient's clinic and who is admitted in psychiatric unit of Assiut university hospitals. This group is further subdivided according to DSM 5 Criteria into 2 subgroups: Major depression with psychotic disorder and Major depression without psychotic disorder. Group (B): control group which consists of (22) healthy cross matching individuals.

You may qualify if:

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

You may not qualify if:

  • Patients under 18 years old or above 60
  • Pregnant or lactating women.
  • Other current or past major psychiatric disorders
  • History or concurrent neurological disease(seizures) or prior head trauma with evidence of consequent cognitive impairment.
  • 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.
  • 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).
  • Patients being treated with steroids or hormonal therapy .
  • Current substances or alcohol use disorders (past diagnosis allowed if in remission for more than 6 months
  • 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
  • Refusal of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 21890211BACKGROUND
  • 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.

    PMID: 28893329BACKGROUND
  • 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.

    PMID: 27755933BACKGROUND
  • 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.

    PMID: 26417770BACKGROUND
  • 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.

    PMID: 26122586BACKGROUND
  • 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.

    PMID: 18945494BACKGROUND
  • 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.

    PMID: 23146253BACKGROUND
  • 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.

    PMID: 26854015BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Yasser Elserogy, MD

    Assiut University

    STUDY CHAIR

Central Study Contacts

Doaa Elhefny, MSC

CONTACT

Romany Jabra, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 24, 2021

First Posted

September 5, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

November 1, 2022

Last Updated

September 5, 2021

Record last verified: 2021-08