Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

Not Applicable

• Conditions: Anxiety Disorders; Major Depressive Disorder
• Interventions: Drug: Sertraline

• Registration Number: NCT04430556
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-11
• Last Update Submitted: 2020-06-11
• Study First Posted: 2020-06-12
• Last Update Posted: 2020-06-12
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volumetric changes in response to sertraline or escitalopram	Sertraline	-

Primary Outcome Measures

Name	Time	Method
Response on Hamilton Anxiety Rating Scale	Change from baseline to week 8	The Hamilton Anxiety Rating Scale and its correlation with hippocampal size

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario Dr. Jose E. Gonzalez; 🇲🇽 Monterrey, Nuevo Leon, Mexico