Psychiatric DisorderGENINCT05480826
Familial and Functional Study of Genetic Variants Identified in People With Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder or Resistant Depression
A study testing study of the transmission of genetic variants in people with Psychiatric Disorder, run by Fondation FondaMental at 1 site in France.
Trial summary
Genetic analyses conducted on patient with psychiatric disorders assessed at the expert centres resulted in the identific action of genetic variants associated with psychiatric disorders (Courtois, 2020). These data require further genetic and functional analyses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- study of the transmission of genetic variants
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2023to 15 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients:
- Subjects suffering from (according to DSM IV criteria) : Bipolar disorder, Unipolar depression, Schizophrenia, Autism spectrum disorder
- Age over 18 years
- Subject affiliated to the social security system
- Including patients under guardianship, curatorship,
- Patients included in the Fondation FondaMental cohort whose genetic analyses have revealed the need for comparative and functional genetic studies.
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- Having signed the consent form
- For relatives :
- Age over 18 years
- Relative of patient included in the Fondattion FondaMental cohort
- Including relative under guardianship, curatorship
- Having signed the consent
- Affiliated to social security
Who cannot join
- For all subjects:
- Any condition that, in the opinion of the investigator, would make the subject's participation in the study undesirable or that would compromise compliance with the protocol
- Persons deprived of liberty
- Inability to understand French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Albert Chenevier
Créteil, 94000
Agnes PELLETIER, MD, PhD, 01.49.81.30.51 ext. +33, agnes.pelletier@aphp.fr
About this study
Genetic analyses conducted on patient with psychiatric disorders assessed at the expert centres resulted in the identific action of genetic variants associated with psychiatric disorders (Courtois, 2020). These data require further genetic and functional analyses. The first objective of this study is to investigate the disease-related inheritance of genetic variants in the families of individuals in whom these variants have been identified. The second objective is to explore the functional consequences of disease-associated genetic variants in patients cells and those of their relatives with and without these variants.
The present project aims to enrich existing biocollections with DNA from blood or saliva from relatives of patients identified with genetic variants. In addition, we wish to collect hair follicules from patients with identified genetic variants of interest and their family members who wish to participate in the study. These hair samples with SNA will be used to dedifferentiate the isolated cells into induced pluripotent stem cells (IPSCs), and then to differentiate them into cells expressing the gene of interest, such as neurons or astrocytes, or into more complex systems, such as brain organoids.
- Conditions
- Psychiatric Disorder
- Being tested
- study of the transmission of genetic variants
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study of the transmission of genetic variantsGenetic
the genetic variants of interest will be investigated by sequencing or genotyping on genomic DNA
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Subject suffering from (according to DSM IV criteria)
* bipolar disorder
* unipolar depression
* schizophrenia
* autism spectrum disorder
Collection of hair follicle cells Receives: Genetic: study of the transmission of genetic variants |
| Relatives | Other | Relatives of enrolled patients suffering from psychiatric disorder.
* test to detect psychiatric disorders
* blood or saliva sampling for genomic DNA extraction
* Collection of hair follicle cells Receives: Genetic: study of the transmission of genetic variants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the probability of having a psychiatric disorder given the presence of the genetic variant studied.
Test for psychiatric disorders Study of the genetic variant of interest by sequencing or genotyping on genomic DNA.
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start15 Mar 2023
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- 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
- Model description
- 2 groups of subjects are enrolled in the study: * patients with a mental disorder * relatives of patients included
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation FondaMental
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion Leboyer, MD PhD, Study chair, Fondation FondaMentalStephane JAMAIN, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480826
- Sponsor's protocol ID
- FF21-GENI
- Other IDs
- 2021-A02551-40
- Acronym
- GENI
- Status last verified
- Apr 2024
- First submitted
- 26 Jul 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial and Functional Study of Genetic Variants Identified in People With Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder or Resistant Depression
- ClinicalTrials.gov ID
- NCT05480826
- Acronym / sponsor ID
- GENI / FF21-GENI
- Conditions
- Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondation FondaMentalUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 29 Jul 2022 (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.
Genetic analyses conducted on patient with psychiatric disorders assessed at the expert centres resulted in the identific action of genetic variants associated with psychiatric disorders (Courtois, 2020). These data require further genetic and functional analyses. The first objective of this study is to investigate the disease-related inheritance of genetic variants in the families of individuals in whom these variants have been identified. The second objective is to explore the functional consequences of disease-associated genetic variants in patients cells and those of their relatives with and without these variants.
The present project aims to enrich existing biocollections with DNA from blood or saliva from relatives of patients identified with genetic variants. In addition, we wish to collect hair follicules from patients with identified genetic variants of interest and their family members who wish to participate in the study. These hair samples with SNA will be used to dedifferentiate the isolated cells into induced pluripotent stem cells (IPSCs), and then to differentiate them into cells expressing the gene of interest, such as neurons or astrocytes, or into more complex systems, such as brain organoids.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups of subjects are enrolled in the study: * patients with a mental disorder * relatives of patients included
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Genetic: study of the transmission of genetic variantsSubject suffering from (according to DSM IV criteria) * bipolar disorder * unipolar depression * schizophrenia * autism spectrum disorder Collection of hair follicle cells |
| Relatives | Other | Genetic: study of the transmission of genetic variantsRelatives of enrolled patients suffering from psychiatric disorder. * test to detect psychiatric disorders * blood or saliva sampling for genomic DNA extraction * Collection of hair follicle cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For patients:
- Subjects suffering from (according to DSM IV criteria) : Bipolar disorder, Unipolar depression, Schizophrenia, Autism spectrum disorder
- Age over 18 years
- Subject affiliated to the social security system
- Including patients under guardianship, curatorship,
Key exclusion criteria (4 listed)
- For all subjects:
- Any condition that, in the opinion of the investigator, would make the subject's participation in the study undesirable or that would compromise compliance with the protocol
- Persons deprived of liberty
- Inability to understand French
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 |
|---|---|---|
| study of the transmission of genetic variantsthe genetic variants of interest will be investigated by sequencing or genotyping on genomic DNA | Genetic | Patients, Relatives |
Primary outcome
Measure of the probability of having a psychiatric disorder given the presence of the genetic variant studied.
Time frame: through study completion, an average of 5 years
Test for psychiatric disorders Study of the genetic variant of interest by sequencing or genotyping on genomic DNA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- 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.
Marion Leboyer, MD PhD study chair
Fondation FondaMental
Stephane JAMAIN, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing study of the transmission of genetic variants in people with Psychiatric Disorder, run by Fondation FondaMental at 1 site in France.
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 13 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Apr 2024. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephane JAMAIN, PhD (149813775 ext. +33, stephane.jamain@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the probability of having a psychiatric disorder given the presence of the genetic variant studied. (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2024.