Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04430556
• Other study ID #: PS18-00016
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Universitario Dr. Jose E. Gonzalez	Monterrey	Nuevo Leon

Sponsors (2)

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

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response on Hamilton Anxiety Rating Scale	The Hamilton Anxiety Rating Scale and its correlation with hippocampal size	Change from baseline to week 8
Secondary	Response on Clinical Global Impression-Improvement	Difference between baseline and final score	Change from baseline to week 8
Secondary	Response on Hamilton Depression Rating Scale	Difference between baseline and final score	Change from baseline to week 8
Secondary	Response on Montgomery-Asberg Scale for Depression	Difference between baseline and final score	Change from baseline to week 8
Secondary	Response on Columbia Scale for Suicidality	Difference between baseline and final score	Change from baseline to week 8
Secondary	Response on State-Trait Depression Inventory	Difference between baseline and final score	Change from baseline to week 8
Secondary	Response on Beck Anxiety Inventory	Difference between baseline and final score	Change from baseline to week 8
Secondary	Response on EQ-5D	Difference between baseline and final score	Change from baseline to week 8