Depression, AnxietyGAPsyNCT06167590
Integrins and Protocadherins in Glutamatergic Circuits: Identification of Common Signaling Pathways and Molecular Targets in Anxiety and Major Depressive Disorders (GAPsy)
A study testing GAPsy protocol in people with Depression, Anxiety and Healthy, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The aim of this study is to identify biologically viable targets for the treatment of major depressive disorder (MDD) and anxiety disorder (AD) with the ultimate goal of guiding physicians' therapeutic strategies and identifying more effective and safer treatments for patients. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Healthy
- What is being tested?
- GAPsy protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2022to 14 Jul 2025
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients group: diagnosis of anxiety-depressive disorder based on the DSM-5 diagnostic criteria; age range between 18 and 35 years; age of onset < 2 years; severe or moderate depression based on scores on the Hamilton Depressive Rating Scale (HAM-D; scores between 14 and 24); severe or moderate anxiety based on scores on the Hamilton Anxiety Rating Scale (HAM-A; scores between 18 and 30); patients must have both severe/moderate depression and anxiety to be included; ability and willingness to provide informed consent and adhere to study procedures.
- Healthy controls group: age range between 18 and 35 years; ability and willingness to provide informed consent and adhere to study procedures.
Who cannot join
- Patients group: diagnosis of other Axis I and/or Axis II psychiatric conditions; substance and/or alcohol abuse and/or dependence; tumors or liver disorders; cognitive impairment.
- Healthy controls: history of Axis I psychiatric conditions in first-degree relatives; presence of preexisting neurological conditions; substance and/or alcohol abuse and/or dependence; cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, MI, 20100
Paolo Brambilla, Professor, + 39 02 55032717, paolo.brambilla1@unimi.it
About this study
The aim of this study is to identify biologically viable targets for the treatment of major depressive disorder (MDD) and anxiety disorder (AD) with the ultimate goal of guiding physicians' therapeutic strategies and identifying more effective and safer treatments for patients. Following the inclusion and exclusion criteria, the investigators will recruit 10 patients with a diagnosis of anxious-depressive disorder (MDD-AD) and 10 healthy controls (HC) subjects. Each participant will be evaluated by a team of expert psychologists and physicians, who will be conducting a structured interview and administering a set of psychopathological scales to assess the symptoms' severity. The participants will also undergo7T multimodal neuroimaging session (including T1-weighted, 1H-MRS and fMRI).
In the second part of the study, murine models will be used to study the role of integrin β3 (Itgb3) and protocadherin 9 (Pcdh9) in glutamatergic transmission at a molecular level and to evaluate whether the electrophysiological and behavioral defects identified in Itgb3- and Pcdh9-knockout mice can be restored by CRISPR-mediated transcription activation (CRISPRa).
Read the detailed description
The study is structured into two parts. In the first part the investigators will be recruiting 10 patients with MDD-AD and 10 HC, following the inclusion and exclusion criteria. Each participant will be evaluated by a team of experienced psychologists and clinicians, administering structured clinical interviews to assess the presence/absence of axis I and II psychiatric disorders (SCID-I and SCID-II) (first visit). Furthermore, in all subjects the degree of depressive/manic dysintomatology will be measured through the use of clinical scales and psychopathological tests such as:the Hamilton Depression Rating Scale (HAM-D), the Montgomery- Asberg Depression rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HAM-A) and the Brief Psychiatric Rating Scale (BPRS)(second visit; within one week of the first screening visit). Moreover, additional clinical data will beextrapolated from medical records and interviews with psychiatrists (if available).
The investigators will also evaluate the suitability of each participant to undergo the multimodal acquisition of Magnetic Resonance Imaging (MRI) data with a 7T GE scanner. The neuroimaging session, performed during the third visit (within one month of the second visit) will include:
- T1-weighted image acquisition: to study the volumetric differences of white and gray matter between subjects in the prefrontal-limbic pathway.
- fMRI: to assess functional connections between prefrontal cortex and limbic system.
- 1H-MRS: to study glutamatergic neurotransmission within the anterior cingulate and dorsolateral prefrontal cortex.
The sequences will be optimized thanks to the 32-channel brain coil (NovaMedical), to reduce artifacts and inhomogeneities in images.
The second part of the study will involve murine models. More specifically, to assess whether Pcdh9 deficits affect the number and morphology of excitatory synapses, electron microscopic analyses will be performed in Pcdh9-knockout mice. Glutamatergic signaling will also be studied at the biochemical level: the expression levels of all major glutamate receptor subunits (ionotropic and metabotropic) will be investigated by analyzing cortical protein lysates (total lysates) in adult mice (3-4 months). In addition, to identify finer changes in glutamate receptor expression, their intracellular and surface expression will be analyzed using the BS3 crosslinking assay.
The investigators will also proceed in the characterization of the interaction between integrin β3 and Protocadherin9 using co-immunoprecipitation analysis from mouse brain: in case of positive results (at least 3 replicates), further analysis will be conducted to study whether the two proteins bind directly.
Electrophysiological characterization of Itgb3 and Pcdh9 murine patterns in the medial prefrontal cortex at both synaptic and local network levels will also be performed and, lastly, an evaluation of functional recovery of behavioral and electrophysiological deficits mediated by CRISPRa will be conducted. In this case, experiments on murine models will be perform to determine whether overexpression of integrin β3 or protocadherin9 could compensate for defects in synaptic glutamatergic transmission caused by deficiencies in CAMs.
- Conditions
- Depression, Anxiety, Healthy
- Being tested
- GAPsy protocol
- Keywords
- Depression, Anxiety, Healthy controls, Neuroimaging, Functional magnetic resonance imaging (fMRI), Proton magnetic resonance spectroscopy (1H-MRS), Murine models, Integrin β3, Protocadherin 9, CRISPR-mediated transcription activation (CRISPRa)
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAPsy protocolDiagnostic test
Each participant will undergo a 7 T multimodal neuroimaging session, including T1-weighted, 1H-MRS and fMRI. Each participant will also be assessed through a structured clinical interview (SCID-I e SCID-II) and will be administered scales such as HAM-A, HAM-D, BPRS and MADRS.
| Study group | Role | What they receive |
|---|---|---|
| Anxious-depressive disorder | Other | Not described Receives: Diagnostic Test: GAPsy protocol |
| Healthy controls | Other | Not described Receives: Diagnostic Test: GAPsy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain structure differences in terms of white matter in the prefrontal-limbic pathway
Evaluation of volumetric differences in terms of white matter in the prefrontal-limbic pathway, comparing the healthy controls group and the patients group, using structural neuroimaging (MRI)
Measured: At T2 (third visit, within a month from the second visit)
Brain structure differences in terms of gray matter in the prefrontal-limbic pathway
Evaluation of volumetric differences in terms of white matter in the prefrontal-limbic pathway, comparing the healthy controls group and the patients group, using structural neuroimaging (MRI)
Measured: At T2 (third visit, within a month from the second visit)
Functional connectivity differences in the prefrontal-limbic pathway
Evaluation of connectivity differences at rest and during task in the prefrontal-limbic pathway, comparing the healthy controls group and the patients group, using functional neuroimaging (fMRI)
Measured: At T2 (third visit, within a month from the second visit)
Differences in the glutamatergic neurotransmission in the anterior cingulate and prefrontal dorsolateral cortices as assessed by using 1H-MRS
Evaluation of glutamatergic neurotransmission differences in the anterior cingulate and prefrontal dorsolateral cortices, comparing the healthy controls group and the patients group, using in vivo proton magnetic resonance spectroscopy (1H-MRS)
Measured: At T2 (third visit, within a month from the second visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start15 Jul 2022
- Primary completion14 Jul 2024 (estimated)
- Study completion14 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CNR Institute of Neuroscience, Parma, University of Trieste, IRCCS Fondazione Stella Maris
- Responsible party
- Sponsor
- Investigators
- Sara Maria Pozzoli, PhD, Principal investigator, S. C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167590
- Sponsor's protocol ID
- GAPsy
- Acronym
- GAPsy
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gorwood P. Generalized anxiety disorder and major depressive disorder comorbidity: an example of genetic pleiotropy? Eur Psychiatry. 2004 Feb;19(1):27-33. doi: 10.1016/j.eurpsy.2003.10.002.
PubMed 14969778Zhou Y, Cao Z, Yang M, Xi X, Guo Y, Fang M, Cheng L, Du Y. Comorbid generalized anxiety disorder and its association with quality of life in patients with major depressive disorder. Sci Rep. 2017 Jan 18;7:40511. doi: 10.1038/srep40511.
PubMed 28098176Jaso BA, Niciu MJ, Iadarola ND, Lally N, Richards EM, Park M, Ballard ED, Nugent AC, Machado-Vieira R, Zarate CA. Therapeutic Modulation of Glutamate Receptors in Major Depressive Disorder. Curr Neuropharmacol. 2017;15(1):57-70. doi: 10.2174/1570159x14666160321123221.
PubMed 26997505Abdallah CG, Jiang L, De Feyter HM, Fasula M, Krystal JH, Rothman DL, Mason GF, Sanacora G. Glutamate metabolism in major depressive disorder. Am J Psychiatry. 2014 Dec 1;171(12):1320-7. doi: 10.1176/appi.ajp.2014.14010067. Epub 2014 Oct 31.
PubMed 25073688Hastings RS, Parsey RV, Oquendo MA, Arango V, Mann JJ. Volumetric analysis of the prefrontal cortex, amygdala, and hippocampus in major depression. Neuropsychopharmacology. 2004 May;29(5):952-9. doi: 10.1038/sj.npp.1300371.
PubMed 14997169
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrins and Protocadherins in Glutamatergic Circuits: Identification of Common Signaling Pathways and Molecular Targets in Anxiety and Major Depressive Disorders (GAPsy)
- ClinicalTrials.gov ID
- NCT06167590
- Acronym / sponsor ID
- GAPsy / GAPsy
- Conditions
- Depression, Anxiety, Healthy
- Keywords
- Depression, Anxiety, Healthy controls, Neuroimaging, Functional magnetic resonance imaging (fMRI), Proton magnetic resonance spectroscopy (1H-MRS), Murine models, Integrin β3, Protocadherin 9
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- CNR Institute of Neuroscience, Parma, University of Trieste, IRCCS Fondazione Stella Maris
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 14 Jul 2024 (estimated)
- Study completion
- 14 Jul 2025 (estimated)
- First posted
- 12 Dec 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.
The aim of this study is to identify biologically viable targets for the treatment of major depressive disorder (MDD) and anxiety disorder (AD) with the ultimate goal of guiding physicians' therapeutic strategies and identifying more effective and safer treatments for patients. Following the inclusion and exclusion criteria, the investigators will recruit 10 patients with a diagnosis of anxious-depressive disorder (MDD-AD) and 10 healthy controls (HC) subjects. Each participant will be evaluated by a team of expert psychologists and physicians, who will be conducting a structured interview and administering a set of psychopathological scales to assess the symptoms' severity. The participants will also undergo7T multimodal neuroimaging session (including T1-weighted, 1H-MRS and fMRI).
In the second part of the study, murine models will be used to study the role of integrin β3 (Itgb3) and protocadherin 9 (Pcdh9) in glutamatergic transmission at a molecular level and to evaluate whether the electrophysiological and behavioral defects identified in Itgb3- and Pcdh9-knockout mice can be restored by CRISPR-mediated transcription activation (CRISPRa).
Detailed description
The study is structured into two parts. In the first part the investigators will be recruiting 10 patients with MDD-AD and 10 HC, following the inclusion and exclusion criteria. Each participant will be evaluated by a team of experienced psychologists and clinicians, administering structured clinical interviews to assess the presence/absence of axis I and II psychiatric disorders (SCID-I and SCID-II) (first visit). Furthermore, in all subjects the degree of depressive/manic dysintomatology will be measured through the use of clinical scales and psychopathological tests such as:the Hamilton Depression Rating Scale (HAM-D), the Montgomery- Asberg Depression rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HAM-A) and the Brief Psychiatric Rating Scale (BPRS)(second visit; within one week of the first screening visit). Moreover, additional clinical data will beextrapolated from medical records and interviews with psychiatrists (if available).
The investigators will also evaluate the suitability of each participant to undergo the multimodal acquisition of Magnetic Resonance Imaging (MRI) data with a 7T GE scanner. The neuroimaging session, performed during the third visit (within one month of the second visit) will include:
- T1-weighted image acquisition: to study the volumetric differences of white and gray matter between subjects in the prefrontal-limbic pathway.
- fMRI: to assess functional connections between prefrontal cortex and limbic system.
- 1H-MRS: to study glutamatergic neurotransmission within the anterior cingulate and dorsolateral prefrontal cortex.
The sequences will be optimized thanks to the 32-channel brain coil (NovaMedical), to reduce artifacts and inhomogeneities in images.
The second part of the study will involve murine models. More specifically, to assess whether Pcdh9 deficits affect the number and morphology of excitatory synapses, electron microscopic analyses will be performed in Pcdh9-knockout mice. Glutamatergic signaling will also be studied at the biochemical level: the expression levels of all major glutamate receptor subunits (ionotropic and metabotropic) will be investigated by analyzing cortical protein lysates (total lysates) in adult mice (3-4 months). In addition, to identify finer changes in glutamate receptor expression, their intracellular and surface expression will be analyzed using the BS3 crosslinking assay.
The investigators will also proceed in the characterization of the interaction between integrin β3 and Protocadherin9 using co-immunoprecipitation analysis from mouse brain: in case of positive results (at least 3 replicates), further analysis will be conducted to study whether the two proteins bind directly.
Electrophysiological characterization of Itgb3 and Pcdh9 murine patterns in the medial prefrontal cortex at both synaptic and local network levels will also be performed and, lastly, an evaluation of functional recovery of behavioral and electrophysiological deficits mediated by CRISPRa will be conducted. In this case, experiments on murine models will be perform to determine whether overexpression of integrin β3 or protocadherin9 could compensate for defects in synaptic glutamatergic transmission caused by deficiencies in CAMs.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxious-depressive disorder | Other | Diagnostic Test: GAPsy protocol |
| Healthy controls | Other | Diagnostic Test: GAPsy protocol |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients group: diagnosis of anxiety-depressive disorder based on the DSM-5 diagnostic criteria; age range between 18 and 35 years; age of onset < 2 years; severe or moderate depression based on scores on the Hamilton Depressive Rating Scale (HAM-D; scores between 14 and 24); severe or moderate anxiety based on scores on the Hamilton Anxiety Rating Scale (HAM-A; scores between 18 and 30); patients must have both severe/moderate depression and anxiety to be included; ability and willingness to provide informed consent and adhere to study procedures.
- Healthy controls group: age range between 18 and 35 years; ability and willingness to provide informed consent and adhere to study procedures.
Key exclusion criteria (2 listed)
- Patients group: diagnosis of other Axis I and/or Axis II psychiatric conditions; substance and/or alcohol abuse and/or dependence; tumors or liver disorders; cognitive impairment.
- Healthy controls: history of Axis I psychiatric conditions in first-degree relatives; presence of preexisting neurological conditions; substance and/or alcohol abuse and/or dependence; cognitive impairment.
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 |
|---|---|---|
| GAPsy protocolEach participant will undergo a 7 T multimodal neuroimaging session, including T1-weighted, 1H-MRS and fMRI. Each participant will also be assessed through a structured clinical interview (SCID-I e SCID-II) and will be administered scales such as HAM-A, HAM-D, BPRS and MADRS. | Diagnostic test | Anxious-depressive disorder, Healthy controls |
Primary outcome
Brain structure differences in terms of white matter in the prefrontal-limbic pathway
Time frame: At T2 (third visit, within a month from the second visit)
Evaluation of volumetric differences in terms of white matter in the prefrontal-limbic pathway, comparing the healthy controls group and the patients group, using structural neuroimaging (MRI)
Brain structure differences in terms of gray matter in the prefrontal-limbic pathway
Time frame: At T2 (third visit, within a month from the second visit)
Evaluation of volumetric differences in terms of white matter in the prefrontal-limbic pathway, comparing the healthy controls group and the patients group, using structural neuroimaging (MRI)
Functional connectivity differences in the prefrontal-limbic pathway
Time frame: At T2 (third visit, within a month from the second visit)
Evaluation of connectivity differences at rest and during task in the prefrontal-limbic pathway, comparing the healthy controls group and the patients group, using functional neuroimaging (fMRI)
Differences in the glutamatergic neurotransmission in the anterior cingulate and prefrontal dorsolateral cortices as assessed by using 1H-MRS
Time frame: At T2 (third visit, within a month from the second visit)
Evaluation of glutamatergic neurotransmission differences in the anterior cingulate and prefrontal dorsolateral cortices, comparing the healthy controls group and the patients group, using in vivo proton magnetic resonance spectroscopy (1H-MRS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Background: PubMed 14969778Gorwood P. Generalized anxiety disorder and major depressive disorder comorbidity: an example of genetic pleiotropy? Eur Psychiatry. 2004 Feb;19(1):27-33. doi: 10.1016/j.eurpsy.2003.10.002.
- Background: PubMed 28098176Zhou Y, Cao Z, Yang M, Xi X, Guo Y, Fang M, Cheng L, Du Y. Comorbid generalized anxiety disorder and its association with quality of life in patients with major depressive disorder. Sci Rep. 2017 Jan 18;7:40511. doi: 10.1038/srep40511.
- Background: PubMed 26997505Jaso BA, Niciu MJ, Iadarola ND, Lally N, Richards EM, Park M, Ballard ED, Nugent AC, Machado-Vieira R, Zarate CA. Therapeutic Modulation of Glutamate Receptors in Major Depressive Disorder. Curr Neuropharmacol. 2017;15(1):57-70. doi: 10.2174/1570159x14666160321123221.
- Background: PubMed 25073688Abdallah CG, Jiang L, De Feyter HM, Fasula M, Krystal JH, Rothman DL, Mason GF, Sanacora G. Glutamate metabolism in major depressive disorder. Am J Psychiatry. 2014 Dec 1;171(12):1320-7. doi: 10.1176/appi.ajp.2014.14010067. Epub 2014 Oct 31.
- Background: PubMed 14997169Hastings RS, Parsey RV, Oquendo MA, Arango V, Mann JJ. Volumetric analysis of the prefrontal cortex, amygdala, and hippocampus in major depression. Neuropsychopharmacology. 2004 May;29(5):952-9. doi: 10.1038/sj.npp.1300371.
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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.
Sara Maria Pozzoli, PhD principal investigator
S. C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAPsy protocol in people with Depression, Anxiety and Healthy, 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 2 inclusion and 2 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 Dec 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 Paolo Brambilla, Professor (02 55035982, paolo.brambilla@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structure differences in terms of white matter in the prefrontal-limbic pathway (time frame: At T2 (third visit, within a month from the second visit)). The study lists 4 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 NCT06167590, which also lists 5 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 12 Dec 2023.