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Familial and Functional Study of Genetic Variants Identified in People With Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder or Resistant Depression (GENI)

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ClinicalTrials.gov Identifier: NCT05480826
Recruitment Status : Recruiting
First Posted : July 29, 2022
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Fondation FondaMental

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Psychiatric Disorder Genetic: study of the transmission of genetic variants Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

2 groups of subjects are enrolled in the study:

  • patients with a mental disorder
  • relatives of patients included
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Familial and Functional Study of Genetic Variants Identified in People With Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder or Resistant Depression
Actual Study Start Date : March 15, 2023
Estimated Primary Completion Date : September 15, 2027
Estimated Study Completion Date : September 15, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Patients

Subject suffering from (according to DSM IV criteria)

  • bipolar disorder
  • unipolar depression
  • schizophrenia
  • autism spectrum disorder

Collection of hair follicle cells

 Genetic: study of the transmission of genetic variants
the genetic variants of interest will be investigated by sequencing or genotyping on genomic DNA
Relatives

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
 Genetic: study of the transmission of genetic variants
the genetic variants of interest will be investigated by sequencing or genotyping on genomic DNA


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05480826


Contacts
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Contact: Stephane JAMAIN, PhD 149813775 ext +33 stephane.jamain@inserm.fr

Locations
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France
Hopital Albert Chenevier Recruiting
Créteil, France, 94000
Contact: Agnes PELLETIER, MD, PhD    01.49.81.30.51 ext +33    agnes.pelletier@aphp.fr   
Sponsors and Collaborators
Fondation FondaMental
Investigators
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Study Chair: Marion Leboyer, MD PhD Fondation FondaMental
Study Director: Stephane JAMAIN, PhD Institut National de la Santé Et de la Recherche Médicale, France
More Information
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Responsible Party: Fondation FondaMental
ClinicalTrials.gov Identifier: NCT05480826    
Other Study ID Numbers: FF21-GENI
2021-A02551-40 ( Other Identifier: French National Agency for the Safety of Medicines and Health Products )
First Posted: July 29, 2022    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Autism Spectrum Disorder
Mental Disorders
Problem Behavior
Behavioral Symptoms
 Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Mood Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders