Brain Hippocampal Volume Relationship With Anxious Sympto... | NCT04430556

Studies
Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

NCT04430556

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Status

Unknown status

Last Update Posted

Jun 12, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Major Depressive Disorder
Anxiety Disorders

Interventions

Sertraline

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 10, 2020

First Submission Date that Met QC Criteria

Jun 11, 2020

First Posted Date

Jun 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2020

Last Update Posted Date

Jun 12, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

José Alfonso Ontiveros Sánchez De la Barquera, Associate Professor, Hospital Universitario Dr. Jose E. GonzalezPrincipal Investigator

Lead Sponsor

Hospital Universitario Dr. Jose E. GonzalezOTHER

Collaborators

Name	Class
Instituto de Información e Investigación en Salud Mental A. C.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Volumetric changes in response to sertraline or escitalopram	Other		Drug: Sertraline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose A Ontiveros Sanchez de la Barquera, MD, PhD	Hospital Universitario Dr. Jose E. Gonzalez	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Dr. Jose E. Gonzalez		Monterrey	Nuevo León	64460	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020280	Sertraline

Ancestor Terms

ID	Term
D015057	1-Naphthylamine
D000588	Amines
D009930	Organic Chemicals
D009281	Naphthalenes

Browse Leaves

Not provided

Browse Branches

Not provided