Psychotic DepressionNCT05034523
Voxel Based Morphometry In Patients With Psychotic Versus Non Psychotic Depression
An observational study of Psychotic Depression and Non Psychotic Depression, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychotic Depression, Non Psychotic Depression
- What is being tested?
- MRI Voxel based morphometry
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Age 18-60 years old.
- Based on DSM5 Criteria: MDD with or without psychotic features.
Who cannot join
- 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).
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
Romany Jabra, MD contact
About this study
- To examine structural brain changes in patients with depression measured using voxel based morphometry(VBM) in comparison with healthy subjects.
- Relation between grey mater volume (GMV) and other structural changes, and the severity of clinical symptoms.
- To study if there is structural brain difference between psychotic and non-psychotic depression
Read the 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 .
- Conditions
- Psychotic Depression, Non Psychotic Depression
- Being tested
- MRI Voxel based morphometry
- Keywords
- Depression, Psychotic depression, Voxel based morphometry
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI Voxel based morphometryRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Psychotic DepressionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Noor Eldin Abdelazeem Mohammed, Assiut University
- Investigators
- Yasser Elserogy, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034523
- Sponsor's protocol ID
- Voxel based MRI in depression
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21890211Jaaskelainen 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.
PubMed 28893329Lui 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.
PubMed 27755933O'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.
PubMed 26417770Schmaal 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.
PubMed 26122586Yuan 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.
PubMed 18945494Lai 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.
PubMed 23146253Arnone 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.
PubMed 26854015
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voxel Based Morphometry In Patients With Psychotic Versus Non Psychotic Depression
- ClinicalTrials.gov ID
- NCT05034523
- Acronym / sponsor ID
- Voxel based MRI in depression
- Conditions
- Psychotic Depression, Non Psychotic Depression
- Keywords
- Depression, Psychotic depression, Voxel based morphometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To examine structural brain changes in patients with depression measured using voxel based morphometry(VBM) in comparison with healthy subjects.
- Relation between grey mater volume (GMV) and other structural changes, and the severity of clinical symptoms.
- To study if there is structural brain difference between psychotic and non-psychotic depression
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Age 18-60 years old.
- Based on DSM5 Criteria: MDD with or without psychotic features.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI Voxel based morphometryVoxel 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. | Radiation | – |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 21890211Sacher 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.
- Background: PubMed 28893329Jaaskelainen 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.
- Background: PubMed 27755933Lui 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.
- Background: PubMed 26417770O'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.
- Background: PubMed 26122586Schmaal 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.
- Background: PubMed 18945494Yuan 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.
- Background: PubMed 23146253Lai 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.
- Background: PubMed 26854015Arnone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romany Jabra, MD contact
Yasser Elserogy, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Depression and Non Psychotic Depression, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa Elhefny, MSC (+201022388263, doaanoors304@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the structural brain changes in different areas in patients with psychotic depression and non-psychotic depression. (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05034523, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.