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In Vitro Modeling of Drug-resistant Psychiatric Disorders Using Induced Pluripotent Cells

NCT05887310 · University of Milano Bicocca

Closed to entry
Status
Not accepting participants
Not applicable
Phase
50
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Major depressive disorder (MDD), is a major medical and economic burden for today's society. About 30% of MDD patients develop treatment-resistant depression - TRD with the related sequelae in terms of worse prognosis. If several risk factors can be assessed readily on presentation, it can guide treatment planning and ultimately improve clinical outcomes. Currently, unlike other areas of medicine, poly-risk tools to facilitate this stratification in practice among patients with MDD are lacking but demanded in the era of personalised/precision medicine - a challenge that the project takes up. Ketamine - a glutamate N-methyl-d-aspartate (NMDA) receptor antagonist, is the first exemplary agent with rapid (within hours) antidepressant effects, even in TRD patients.Its mechanisms of actions (MoA) are still unclear but greatly demanded. So far, insights about ketamine's MoA come from preclinical animal studies but it's known that animal models have limited ability/effectiveness in mimicking the clinical complexity and were not subjected to sequential application of different treatments - a key requisite in humans to be defined as TRD. This ambitious inter/multidisciplinary project, has 3 goals: 1. To develop a clinical risk stratification tool for predicting TRD development. 2. To unravel ketamine's fast-acting antidepressant mechanisms of action (MoA) on mature neurons obtained from human induced pluripotent stem cells (iPSCs) obtained from (ketamine-responsive \& non-responsive) patients with TRD. 3. To give maximum visibility to the project and spreading its contents \& findings to and in a way understood by all target groups variously implicated/interested in project research \& innovation.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Create in vitro human cellular models of some drug-resistant psychiatric disorders.

    Measured over Entire study duration (approximately 10 years)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion criteria: * Age ≥ 18 years; * Diagnosis, confirmed through the Structured Clinical Interview for DSM-5, of: * Schizophrenic spectrum disorder; * Bipolar spectrum disorder; * Depressive Disorder * Obsessive-Compulsive Disorder * Anxiety Disorder; * Clear evidence of drug resistance (defined, according to the EMA criteria and the literature, as failure at a minimum of 2 treatments set for adequate dosage and duration); * Informed consent freely granted and acquired before the start of the study Exclusion Criteria * Age ≥ 80 years; * History of drug abuse; * Comorbidity with neurodegenerative neurological disorders; * Diagnosis of Intellectual Disability

Where

1 study site

FacilityCityRegionCountry
Fondazione IRCCS San Gerardo di MonzaMonzaMonza E BrianzaItaly

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05887310 on ClinicalTrials.gov →

Last updated in the registry 2023-06-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits