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

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety Disorders; Major Depressive Disorder
• Intervention / Treatment: Drug: Sertraline

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Hospital Universitario Dr. Jose E. Gonzalez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Volumetric changes in response to sertraline or escitalopram	Drug: Sertraline; Sertraline will be started in all patients, unless it is contraindicated, in this case, Escitalopram will be indicated.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Collaborators: Instituto de Información e Investigación en Salud Mental A. C.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (ACTUAL): June 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: MRI; anxiety; major depressive disorder; cortisol; c-reactive protein; brain metabolites; hippocampal volume
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Anxiety Disorders; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: PS18-00016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No