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Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

Primary Purpose

Major Depressive Disorder, Anxiety Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Sertraline
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Major Depressive Disorder focused on measuring major depressive disorder, hippocampal volume, cortisol, c-reactive protein, brain metabolites, MRI, anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Dr. Jose E. Gonzalez

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Volumetric changes in response to sertraline or escitalopram

Arm Description

Outcomes

Primary Outcome Measures

Response on Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale and its correlation with hippocampal size

Secondary Outcome Measures

Response on Clinical Global Impression-Improvement
Difference between baseline and final score
Response on Hamilton Depression Rating Scale
Difference between baseline and final score
Response on Montgomery-Asberg Scale for Depression
Difference between baseline and final score
Response on Columbia Scale for Suicidality
Difference between baseline and final score
Response on State-Trait Depression Inventory
Difference between baseline and final score
Response on Beck Anxiety Inventory
Difference between baseline and final score
Response on EQ-5D
Difference between baseline and final score

Full Information

First Posted
June 10, 2020
Last Updated
June 11, 2020
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborators
Instituto de Información e Investigación en Salud Mental A. C.
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1. Study Identification

Unique Protocol Identification Number
NCT04430556
Brief Title
Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients
Official Title
Study on the Brain Hippocampal Volume, Cortisol and C-reactive Protein Levels Relationship With Anxious Symptoms in Major Depressive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborators
Instituto de Información e Investigación en Salud Mental A. C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Anxiety Disorders
Keywords
major depressive disorder, hippocampal volume, cortisol, c-reactive protein, brain metabolites, MRI, anxiety

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Volumetric changes in response to sertraline or escitalopram
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Description
Sertraline will be started in all patients, unless it is contraindicated, in this case, Escitalopram will be indicated.
Primary Outcome Measure Information:
Title
Response on Hamilton Anxiety Rating Scale
Description
The Hamilton Anxiety Rating Scale and its correlation with hippocampal size
Time Frame
Change from baseline to week 8
Secondary Outcome Measure Information:
Title
Response on Clinical Global Impression-Improvement
Description
Difference between baseline and final score
Time Frame
Change from baseline to week 8
Title
Response on Hamilton Depression Rating Scale
Description
Difference between baseline and final score
Time Frame
Change from baseline to week 8
Title
Response on Montgomery-Asberg Scale for Depression
Description
Difference between baseline and final score
Time Frame
Change from baseline to week 8
Title
Response on Columbia Scale for Suicidality
Description
Difference between baseline and final score
Time Frame
Change from baseline to week 8
Title
Response on State-Trait Depression Inventory
Description
Difference between baseline and final score
Time Frame
Change from baseline to week 8
Title
Response on Beck Anxiety Inventory
Description
Difference between baseline and final score
Time Frame
Change from baseline to week 8
Title
Response on EQ-5D
Description
Difference between baseline and final score
Time Frame
Change from baseline to week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A Ontiveros Sanchez de la Barquera, MD, PhD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Dr. Jose E. Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

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