Post-partum DepressionNCT06131255
DRACULA1 Partum Depression: an Integrated Molecular-pharmaco-imaging Study")
An observational study of Post-partum Depression, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Post-partum Depression
- What is being tested?
- Citalopram
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 30 Apr 2026
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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);
Show all 10Show fewer
- 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.
Who cannot join
- 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);
Show all 9Show fewer
- presence of contraindications for MRI scanning;
- presence of contraindications for citalopram;
- patients who have not signed informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, MI, 20100
About this study
Official title: ("The Role of the Glutamatergic Neurotransmission in Post- Partum Depression: an Integrated Molecular-pharmaco-imaging Study")
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.
Read 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 Foundation upon referral from the S.C. Psychiatry of the same institution. In the study, exposure to citalopram treatment will be 12 weeks with follow-up every 4 weeks. At each participant, at the time of enrollment, will be assigned a unique code so that only the local investigators can trace the subject's identity. As part of a scheduled visit to assess the clinical diagnosis, the PPD patient will be offered to participate in the study, after the appropriate signing of informed consent, the verification of absence of criteria for exclusion and existence of the study inclusion criteria. If these criteria are met, some demographic and clinical medical history of the women with PPD will be collected, as already provided by clinical practice for the management of the disease. Patients will undergo MRI scanning at baseline at the S.C. Neuroradiology of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and will begin the pharmacological treatment with citalopram. It is emphasized that the administration of citalopram therapy for the treatment of depressive symptomatology will be proposed and carried out in the patient due to clinical needs, based on the judgment of the competent physician and as would already be the case in practice, thus completely independent of participation or non-participation in the present study. Neuroimaging data will be obtained with a Philips 3T magnetic resonance imaging MRI machine. For each patient enrolled in the study, a structural T1 sequence (3D MPRAGE) is acquired.
T1-weighted MRI images will be used to study the differences brain morphology, including the volumes of gray matter (GM) and white matter (WM) and voxel-based morphometry. In a comparison parallel between regions of interest (ROIs), regional volumes will be estimated using the automated anatomical labeling atlas (AAL) as a reference, with emphasis on the dorsolateral PFC (DL)/ventrolateral (VL), cingulate cortex, amygdala and hippocampus. Further regional analysis will allow estimation, in addition to cortical volumes and subcortical volumes, cortical thickness, cortical surface area, and the cortical gyrification of the Desikan-Killiany atlas regions. During treatment with citalopram, patients will be visited, as per standard clinical practice, every 4 weeks. At each of these follow-up visits will be administered to patients by medical specialists the Brief Psychiatric Rating Scale (BPRS) and the Hamilton Depression Rating Scale (HAM- D) to study symptomatology depression. Patients will be, instead, self-administered in Italian language the Maternal Postnatal Attachment Scale (MPAS) and the Parental Stress Index (PSI) to investigate mother-child attachment and parental stress. The time scheduled for completion of both scales will be about 40 minutes. At 12 weeks, as per practice, the MRI scan will be repeated at the S.C. Neuroradiology Department of the Foundation. The following variables will be collected as part of this study: socio-demographic variables (age, schooling, socio-economic);
- clinical/anamnestic variables (age of onset, duration of untreated treated, drug therapy, comorbidities, familiarity, substance abuse/dependence);
- BPRS and HAM-D scales scores for symptomatology assessment (T0, T1, T2, T3);
- MPAS and PSI scales scores for the assessment of mothers child attachment. (T0, T1, T2, T3);
- MRI scan data (T0, T3): the images will be used to study brain morphological differences, including GM and WM volumes, and voxel-based morphometry. In a parallel comparison between regions of interest (ROI), regional volumes will be estimated using as a reference the automated anatomical labeling atlas (AAL), with particular attention to the dorsolateral (DL)/ventrolateral (VL) PFC, cingulate cortex, amygdala and hippocampus. A further regional analysis will make it possible to estimate, in addition to cortical and subcortical volumes, the thickness cortical, cortical surface area and cortical gyrification of the Desikan-Killiany atlas regions.
- Conditions
- Post-partum Depression
- Being tested
- Citalopram
- Keywords
- post-partum depression, glutamatergic neurotransmission, antidepressants, citalopram
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Variation of the score of HAM-D for measuring patients' symptomatology after 12 weeks after the start of treatment. Patients will be considered responsive if they have at least a 30% reduction from baseline HAM-D baseline after 12 weeks of treatment with citalopram.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post-partum DepressionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131255
- Sponsor's protocol ID
- DRACULA 1
- Status last verified
- Mar 2023
- First submitted
- 13 Apr 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22982106Bambico 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.
PubMed 23271325Boku 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.
PubMed 28926161Bruining 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.
PubMed 25802080Cingolani 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.
PubMed 18549786Davis 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.
PubMed 31471185Postpartum 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.
PubMed 26359613Duric 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.
PubMed 22339950
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ("The Role of the Glutamatergic Neurotransmission in Post- Partum Depression: an Integrated Molecular-pharmaco-imaging Study")
- ClinicalTrials.gov ID
- NCT06131255
- Acronym / sponsor ID
- DRACULA 1
- Conditions
- Post-partum Depression
- Keywords
- post-partum depression, glutamatergic neurotransmission, antidepressants, citalopram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 14 Nov 2023 (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.
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.
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 Foundation upon referral from the S.C. Psychiatry of the same institution. In the study, exposure to citalopram treatment will be 12 weeks with follow-up every 4 weeks. At each participant, at the time of enrollment, will be assigned a unique code so that only the local investigators can trace the subject's identity. As part of a scheduled visit to assess the clinical diagnosis, the PPD patient will be offered to participate in the study, after the appropriate signing of informed consent, the verification of absence of criteria for exclusion and existence of the study inclusion criteria. If these criteria are met, some demographic and clinical medical history of the women with PPD will be collected, as already provided by clinical practice for the management of the disease. Patients will undergo MRI scanning at baseline at the S.C. Neuroradiology of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and will begin the pharmacological treatment with citalopram. It is emphasized that the administration of citalopram therapy for the treatment of depressive symptomatology will be proposed and carried out in the patient due to clinical needs, based on the judgment of the competent physician and as would already be the case in practice, thus completely independent of participation or non-participation in the present study. Neuroimaging data will be obtained with a Philips 3T magnetic resonance imaging MRI machine. For each patient enrolled in the study, a structural T1 sequence (3D MPRAGE) is acquired.
T1-weighted MRI images will be used to study the differences brain morphology, including the volumes of gray matter (GM) and white matter (WM) and voxel-based morphometry. In a comparison parallel between regions of interest (ROIs), regional volumes will be estimated using the automated anatomical labeling atlas (AAL) as a reference, with emphasis on the dorsolateral PFC (DL)/ventrolateral (VL), cingulate cortex, amygdala and hippocampus. Further regional analysis will allow estimation, in addition to cortical volumes and subcortical volumes, cortical thickness, cortical surface area, and the cortical gyrification of the Desikan-Killiany atlas regions. During treatment with citalopram, patients will be visited, as per standard clinical practice, every 4 weeks. At each of these follow-up visits will be administered to patients by medical specialists the Brief Psychiatric Rating Scale (BPRS) and the Hamilton Depression Rating Scale (HAM- D) to study symptomatology depression. Patients will be, instead, self-administered in Italian language the Maternal Postnatal Attachment Scale (MPAS) and the Parental Stress Index (PSI) to investigate mother-child attachment and parental stress. The time scheduled for completion of both scales will be about 40 minutes. At 12 weeks, as per practice, the MRI scan will be repeated at the S.C. Neuroradiology Department of the Foundation. The following variables will be collected as part of this study: socio-demographic variables (age, schooling, socio-economic);
- clinical/anamnestic variables (age of onset, duration of untreated treated, drug therapy, comorbidities, familiarity, substance abuse/dependence);
- BPRS and HAM-D scales scores for symptomatology assessment (T0, T1, T2, T3);
- MPAS and PSI scales scores for the assessment of mothers child attachment. (T0, T1, T2, T3);
- MRI scan data (T0, T3): the images will be used to study brain morphological differences, including GM and WM volumes, and voxel-based morphometry. In a parallel comparison between regions of interest (ROI), regional volumes will be estimated using as a reference the automated anatomical labeling atlas (AAL), with particular attention to the dorsolateral (DL)/ventrolateral (VL) PFC, cingulate cortex, amygdala and hippocampus. A further regional analysis will make it possible to estimate, in addition to cortical and subcortical volumes, the thickness cortical, cortical surface area and cortical gyrification of the Desikan-Killiany atlas regions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with Post-Partum Depression | – | Drug: Citalopram15 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| CitalopramPatients 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 | Drug | Women with Post-Partum Depression |
Primary outcome
Evaluate the citalopram effect on white matter morphology
Time frame: 12 weeks
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.
Evaluate the citalopram effect on gray matter morphology
Time frame: 12 weeks
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.
1 secondary outcome
To evaluate the efficacy of citalopram on the clinical symptomatology of the PPD patients through the use of clinical scales
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 22982106Asahina 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.
- Background: PubMed 23271325Bambico 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.
- Background: PubMed 28926161Boku 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.
- Background: PubMed 25802080Bruining 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.
- Background: PubMed 18549786Cingolani 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.
- Background: PubMed 31471185Davis 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.
- Background: PubMed 26359613Postpartum 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.
- Background: PubMed 22339950Duric 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-partum Depression, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 10 inclusion and 9 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 14 Nov 2023. 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 Italy. 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?
Contact Domenica mercadante, doctor (02 5503 2234, domenica.mercadante@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the citalopram effect on white matter morphology (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06131255, which also lists 8 linked publications.
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 14 Nov 2023.