Status:
NOT_YET_RECRUITING
DRACULA1 Partum Depression: an Integrated Molecular-pharmaco-imaging Study")
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Post-partum Depression
Eligibility:
FEMALE
18-40 years
Brief Summary
Post-partum depression (PPD) is a prevalent subtype of major depressive disorder that causes a significant distress to the woman and substantial impact on the whole family. Many studies implicate the ...
Detailed Description
Patients will be recruited by the physician in charge of the study or collaborators of the S.C. Neonatology and Neonatal Intensive Care Unit of the IRCCS Ca' Granda Ospedale Maggiore Policlinico Found...
Eligibility Criteria
Inclusion
- Age between 18 and 40 years;
- female gender;
- PPD diagnosed by DSM-5 structured clinical interview support (SCID-5) by trained medical personnel;
- comorbidity with metabolic syndrome, which can lead to brain damage and cognitive flaws;
- need to start citalopram therapy for clinical needs (and therefore independent of study participation) or already on therapy for no more than two weeks;
- moderate to severe depression according to the 17-item HAM-D (score 14-24);
- absence of disabling medical and/or neurological conditions, including heart attacks, brain injuries, neurodegenerative diseases, head trauma with loss of consciousness for more than 30 minutes;
- Absence of concomitant psychiatric therapies (antidepressants, antipsychotics of the first and second generation and mood stabilizers);
- absence of contraindications for MRI scanning;
- patients who have signed informed consent.
Exclusion
- age below 18 years or above 40 years;
- diagnosis different from PPD based on SCID-5;
- absence of metabolic syndrome;
- low depression according to the 17-item HAM-D (score less than 14);
- presence of disabling medical and/or neurological conditions, including heart attacks, brain injuries, neurodegenerative diseases, head trauma with loss of consciousness for more than 30 minutes;
- presence of concomitant drug therapies (antidepressants, first- and second-generation antipsychotics and mood stabilizers);
- presence of contraindications for MRI scanning;
- presence of contraindications for citalopram;
- patients who have not signed informed consent.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06131255
Start Date
January 1 2024
End Date
April 30 2026
Last Update
November 14 2023
Active Locations (1)
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1
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, MI, Italy, 20100