Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depressive Disorder, Anxiety Disorders

Intervention / Treatment
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* Drug: Sertraline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Volumetric changes in response to sertraline or escitalopram<br> | Drug: Sertraline<br>* Sertraline will be started in all patients, unless it is contraindicated, in this case, Escitalopram will be indicated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response on Hamilton Anxiety Rating Scale | The Hamilton Anxiety Rating Scale and its correlation with hippocampal size | Change from baseline to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response on Clinical Global Impression-Improvement | Difference between baseline and final score | Change from baseline to week 8 | 
| Response on Hamilton Depression Rating Scale | Difference between baseline and final score | Change from baseline to week 8 | 
| Response on Montgomery-Asberg Scale for Depression | Difference between baseline and final score | Change from baseline to week 8 | 
| Response on Columbia Scale for Suicidality | Difference between baseline and final score | Change from baseline to week 8 | 
| Response on State-Trait Depression Inventory | Difference between baseline and final score | Change from baseline to week 8 | 
| Response on Beck Anxiety Inventory | Difference between baseline and final score | Change from baseline to week 8 | 
| Response on EQ-5D | Difference between baseline and final score | Change from baseline to week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, cortisol, anxiety, major depressive disorder, hippocampal volume, c-reactive protein, brain metabolites