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Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

Study on the Brain Hippocampal Volume, Cortisol and C-reactive Protein Levels Relationship With Anxious Symptoms in Major Depressive Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04430556
Enrollment
30
Registered
2020-06-12
Start date
2018-07-01
Completion date
2020-12-31
Last updated
2020-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Major Depressive Disorder

Keywords

major depressive disorder, hippocampal volume, cortisol, c-reactive protein, brain metabolites, MRI, anxiety

Brief summary

The objective of this transversal study is to determine if there is a difference in the volume of the hippocampus with the degree of anxiety.

Interventions

DRUGSertraline

Sertraline will be started in all patients, unless it is contraindicated, in this case, Escitalopram will be indicated.

Sponsors

Instituto de Información e Investigación en Salud Mental A. C.
CollaboratorUNKNOWN
Hospital Universitario Dr. Jose E. Gonzalez
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* First-time patients, without prior antidepressant treatment that meet the diagnostic criteria of DSM 5 for major depressive disorder. * Patients who meet the current major depressive disorder criteria in the MINI interview. * Patients who signed the informed consent for the investigation.

Exclusion criteria

* Patients presenting insufficient data in the MINI interview for current major depression. * Patients diagnosed with intellectual development disorder, by clinic. * Patients with diagnosis of the schizophrenic spectrum, bipolar disorder, autism spectrum disorder, post-traumatic stress disorder and obsessive-compulsive disorder by clinic and / or by the MINI interview. * Patients with contraindications for MRI. * Patients with serious or unstable medical problems. * Patients undergoing some legal procedure. * Patients with difficulties in understanding the interview or completing the assessment instruments.

Design outcomes

Primary

MeasureTime frameDescription
Response on Hamilton Anxiety Rating ScaleChange from baseline to week 8The Hamilton Anxiety Rating Scale and its correlation with hippocampal size

Secondary

MeasureTime frameDescription
Response on Hamilton Depression Rating ScaleChange from baseline to week 8Difference between baseline and final score
Response on Montgomery-Asberg Scale for DepressionChange from baseline to week 8Difference between baseline and final score
Response on Columbia Scale for SuicidalityChange from baseline to week 8Difference between baseline and final score
Response on Clinical Global Impression-ImprovementChange from baseline to week 8Difference between baseline and final score
Response on Beck Anxiety InventoryChange from baseline to week 8Difference between baseline and final score
Response on EQ-5DChange from baseline to week 8Difference between baseline and final score
Response on State-Trait Depression InventoryChange from baseline to week 8Difference between baseline and final score

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026