DRACULA1 Partum Depression: an Integrated Molecular-pharmaco-imaging Study")

NCT06131255 | Not Yet Recruiting

• 1 other identifier: DRACULA 1
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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 glutamatergic system in pathological processes relevant to PPD disorders. There is evidence that cell adhesion molecules (CAMs) play a key role in how glutamatergic circuits wire up during development and how glutamatergic synapses, once formed, operate. However, it is unclear how dysregulation in diverse CAMs alter glutamatergic circuitries responsible for emotional and social behavior. Here, the investigators propose to evaluate the molecular and neurobiological underpinnings of PPD focusing on CAMs at glutamatergic synapses by using an integrated approach from mouse models to human patients. Moreover, the investigators will also perform a pilot study to investigate the impact of selective antidepressants, known to be linked to CAMs, in both human and mice.

Conditions

Post-partum Depression

Keywords

post-partum depression; glutamatergic neurotransmission; antidepressants; citalopram

Outcome Measures

Primary Outcomes (2)

• Evaluate the citalopram effect on white matter morphology

  Any statistically significant changes in brain volumetry and in the tissue amount of white matter (WM) will be evaluated after 12 weeks of treatment with citalopram.

  12 weeks

• Evaluate the citalopram effect on gray matter morphology

  Any statistically significant changes in brain volumetry and in the tissue amount of gray matter (GM) will be evaluated after 12 weeks of treatment with citalopram.

  12 weeks

Secondary Outcomes (1)

• To evaluate the efficacy of citalopram on the clinical symptomatology of the PPD patients through the use of clinical scales

  12 weeks

Other Outcomes (1)

• Assess the tolerability profile of the drug in the same patients

  12 weeks

Study Arms (1)

Women with Post-Partum Depression

15 women with PPD referred to the S.C. Psychiatry of IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation and referred to the S.C. Neonatology and Neonatal Intensive Care Unit of the same institution for enrollment.

Drug: Citalopram

Interventions

Citalopram DRUG

Patients will be administered citalopram, regardless of inclusion or non-inclusion in this study, on medical indication, as per normal clinical practice for disease management and according to the Summary of Product Characteristics (SPC). Patients will have two MRI scans done (at baseline and at 12 weeks after the start of therapy) to assess: brain volumetry, tissue amount of gray matter - GM - and white matter - WM

Women with Post-Partum Depression

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women, aged 18 years to 40 years of age or older, with PPD who will be enrolled by the S.C. Neonatology and Neonatal Intensive Care Unit of the IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation upon referral from the S.C. Psychiatry of the same institution.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, MI, 20100, Italy

Location

Related Publications (8)

• Asahina H, Masuba A, Hirano S, Yuri K. Distribution of protocadherin 9 protein in the developing mouse nervous system. Neuroscience. 2012 Dec 6;225:88-104. doi: 10.1016/j.neuroscience.2012.09.006. Epub 2012 Sep 11.

  PMID: 22982106 BACKGROUND

• Bambico FR, Belzung C. Novel insights into depression and antidepressants: a synergy between synaptogenesis and neurogenesis? Curr Top Behav Neurosci. 2013;15:243-91. doi: 10.1007/7854_2012_234.

  PMID: 23271325 BACKGROUND

• Boku S, Nakagawa S, Toda H, Hishimoto A. Neural basis of major depressive disorder: Beyond monoamine hypothesis. Psychiatry Clin Neurosci. 2018 Jan;72(1):3-12. doi: 10.1111/pcn.12604. Epub 2017 Oct 19.

  PMID: 28926161 BACKGROUND

• Bruining H, Matsui A, Oguro-Ando A, Kahn RS, Van't Spijker HM, Akkermans G, Stiedl O, van Engeland H, Koopmans B, van Lith HA, Oppelaar H, Tieland L, Nonkes LJ, Yagi T, Kaneko R, Burbach JP, Yamamoto N, Kas MJ. Genetic Mapping in Mice Reveals the Involvement of Pcdh9 in Long-Term Social and Object Recognition and Sensorimotor Development. Biol Psychiatry. 2015 Oct 1;78(7):485-95. doi: 10.1016/j.biopsych.2015.01.017. Epub 2015 Feb 7.

  PMID: 25802080 BACKGROUND

• Cingolani LA, Thalhammer A, Yu LM, Catalano M, Ramos T, Colicos MA, Goda Y. Activity-dependent regulation of synaptic AMPA receptor composition and abundance by beta3 integrins. Neuron. 2008 Jun 12;58(5):749-62. doi: 10.1016/j.neuron.2008.04.011.

  PMID: 18549786 BACKGROUND

• Davis AD, Hassel S, Arnott SR, Harris J, Lam RW, Milev R, Rotzinger S, Zamyadi M, Frey BN, Minuzzi L, Strother SC, MacQueen GM, Kennedy SH, Hall GB. White Matter Indices of Medication Response in Major Depression: A Diffusion Tensor Imaging Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2019 Oct;4(10):913-924. doi: 10.1016/j.bpsc.2019.05.016. Epub 2019 Jun 12.

  PMID: 31471185 BACKGROUND

• Postpartum Depression: Action Towards Causes and Treatment (PACT) Consortium. Heterogeneity of postpartum depression: a latent class analysis. Lancet Psychiatry. 2015 Jan;2(1):59-67. doi: 10.1016/S2215-0366(14)00055-8. Epub 2015 Jan 8.

  PMID: 26359613 BACKGROUND

• Duric V, Banasr M, Stockmeier CA, Simen AA, Newton SS, Overholser JC, Jurjus GJ, Dieter L, Duman RS. Altered expression of synapse and glutamate related genes in post-mortem hippocampus of depressed subjects. Int J Neuropsychopharmacol. 2013 Feb;16(1):69-82. doi: 10.1017/S1461145712000016. Epub 2012 Feb 17.

  PMID: 22339950 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Domenica mercadante, doctor

CONTACT

02 5503 2234; domenica.mercadante@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: November 14, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 30, 2026
• Last Updated: November 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)