Voxel Based Morphometry In Patients With Psychotic Versus Non Psychotic Depression

August 29, 2021 updated by: Doaa Noor Eldin Abdelazeem Mohammed, Assiut University
  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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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 .

Study Type

Observational

Enrollment (Anticipated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study the structural brain changes in different areas in patients with psychotic depression and non-psychotic depression.
Time Frame: one year
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
Time Frame: one year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Yasser Elserogy, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 29, 2021

First Posted (ACTUAL)

September 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 29, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Voxel based MRI in depression

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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