Major Depressive DisorderNCT04430556
Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients
A study testing Sertraline in people with Major Depressive Disorder and Anxiety Disorders, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Anxiety Disorders
- What is being tested?
- Sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, 64460
About this study
Official title: Study on the Brain Hippocampal Volume, Cortisol and C-reactive Protein Levels Relationship With Anxious Symptoms in Major Depressive Patients
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
- Being tested
- Sertraline
- Keywords
- major depressive disorder, hippocampal volume, cortisol, c-reactive protein, brain metabolites, MRI, anxiety
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Sertraline will be started in all patients, unless it is contraindicated, in this case, Escitalopram will be indicated.
| Study group | Role | What they receive |
|---|---|---|
| Volumetric changes in response to sertraline or escitalopram | Other | Not described Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response on Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale and its correlation with hippocampal size
Measured: Change from baseline to week 8
Secondary outcomes (7)
Response on Clinical Global Impression-Improvement
Difference between baseline and final score
Measured: Change from baseline to week 8
Response on Hamilton Depression Rating Scale
Difference between baseline and final score
Measured: Change from baseline to week 8
Response on Montgomery-Asberg Scale for Depression
Difference between baseline and final score
Measured: Change from baseline to week 8
Response on Columbia Scale for Suicidality
Difference between baseline and final score
Measured: Change from baseline to week 8
Response on State-Trait Depression Inventory
Difference between baseline and final score
Measured: Change from baseline to week 8
Response on Beck Anxiety Inventory
Difference between baseline and final score
Measured: Change from baseline to week 8
Response on EQ-5D
Difference between baseline and final score
Measured: Change from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Jul 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Información e Investigación en Salud Mental A. C.
- Responsible party
- Principal investigator, José Alfonso Ontiveros Sánchez De la Barquera, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Jose A Ontiveros Sanchez de la Barquera, MD, PhD, Study chair, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430556
- Sponsor's protocol ID
- PS18-00016
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Brain Hippocampal Volume, Cortisol and C-reactive Protein Levels Relationship With Anxious Symptoms in Major Depressive Patients
- ClinicalTrials.gov ID
- NCT04430556
- Acronym / sponsor ID
- PS18-00016
- Conditions
- Major Depressive Disorder, Anxiety Disorders
- Keywords
- major depressive disorder, hippocampal volume, cortisol, c-reactive protein, brain metabolites, MRI, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Collaborators
- Instituto de Información e Investigación en Salud Mental A. C.
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volumetric changes in response to sertraline or escitalopram | Other | Drug: Sertraline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineSertraline will be started in all patients, unless it is contraindicated, in this case, Escitalopram will be indicated. | Drug | Volumetric changes in response to sertraline or escitalopram |
Primary outcome
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
7 secondary outcomes
Response on Clinical Global Impression-Improvement
Time frame: Change from baseline to week 8
Response on Hamilton Depression Rating Scale
Time frame: Change from baseline to week 8
Response on Montgomery-Asberg Scale for Depression
Time frame: Change from baseline to week 8
Response on Columbia Scale for Suicidality
Time frame: Change from baseline to week 8
Response on State-Trait Depression Inventory
Time frame: Change from baseline to week 8
Response on Beck Anxiety Inventory
Time frame: Change from baseline to week 8
Response on EQ-5D
Time frame: Change from baseline to week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A Ontiveros Sanchez de la Barquera, MD, PhD study chair
Hospital Universitario Dr. Jose E. Gonzalez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertraline in people with Major Depressive Disorder and Anxiety Disorders, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response on Hamilton Anxiety Rating Scale (time frame: Change from baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.