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Clinical Trials/NCT04430556
NCT04430556
Unknown
Not Applicable

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

Hospital Universitario Dr. Jose E. Gonzalez1 site in 1 country30 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Sertraline
Conditions
Major Depressive Disorder
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Enrollment
30
Locations
1
Primary Endpoint
Response on Hamilton Anxiety Rating Scale
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
December 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Responsible Party
Principal Investigator
Principal Investigator

José Alfonso Ontiveros Sánchez De la Barquera

Associate Professor

Hospital Universitario Dr. Jose E. Gonzalez

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.

Arms & Interventions

Volumetric changes in response to sertraline or escitalopram

Intervention: Sertraline

Outcomes

Primary Outcomes

Response on Hamilton Anxiety Rating Scale

Time Frame: Change from baseline to week 8

The Hamilton Anxiety Rating Scale and its correlation with hippocampal size

Secondary Outcomes

  • Response on Montgomery-Asberg Scale for Depression(Change from baseline to week 8)
  • Response on Hamilton Depression Rating Scale(Change from baseline to week 8)
  • Response on Clinical Global Impression-Improvement(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)
  • Response on Beck Anxiety Inventory(Change from baseline to week 8)
  • Response on EQ-5D(Change from baseline to week 8)

Study Sites (1)

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