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.
Investigators
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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