Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

NCT04430556 | Unknown

• 1 other identifier: PS18-00016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Anxiety Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response on Hamilton Anxiety Rating Scale

  The Hamilton Anxiety Rating Scale and its correlation with hippocampal size

  Change from baseline to week 8

Secondary Outcomes (7)

• Response on Clinical Global Impression-Improvement

  Change from baseline to week 8

• Response on Hamilton Depression Rating Scale

  Change from baseline to week 8

• Response on Montgomery-Asberg Scale for Depression

  Change from baseline to week 8

• Response on Columbia Scale for Suicidality

  Change from baseline to week 8

• Response on State-Trait Depression Inventory

  Change from baseline to week 8

Study Arms (1)

Volumetric changes in response to sertraline or escitalopram

OTHER

Drug: Sertraline

Interventions

Sertraline DRUG

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

Volumetric changes in response to sertraline or escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Jose A Ontiveros Sanchez de la Barquera, MD, PhD

  Hospital Universitario Dr. Jose E. Gonzalez

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: July 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

ME (1)