Premorbid Personality Profile of Patients With Cognitive and Behavioral Disorders

Bipolar Disorder Clinical Trial

Official title:

Relationship Between Premorbid Personality Traits and Cognitive and Behavioral Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06059313
• Other study ID #: RC23_0343
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: September 2023
• Source: Nantes University Hospital
• Contact: Claire BOUTOLEAU-BRETONNIERE, PH
• Phone: 33 2 40 16 54 22
• Email: claire.boutoleaubretonniere[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Damages in frontal area present in neurodegenerative disease (frontotemporal degeneration, frontal variant of Alzheimer disease) and in psychiatric disease (bipolar disorder) can affect behavior and cognition including social cognition. Symptoms vary both quantitatively and qualitatively from disease to another and from person to person. It cannot be completely excluded that in some cases, factors of susceptibility such as premorbid personality traits lead to frontal fragility.

The study will assess the relationship between premorbid profile using NEO-PI 3 inventory and cognitive and behavioral/psychobehavioral manifestations in patients with behavioral variant of frontotemporal disorder (bvFTD), phenocopy frontotemporal dementia (phFTD), frontal variant of Alzheimer disease, bipolar disorder characterized with frontal damages.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 1, 2027
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• Patients with behavioral variant of frontotemporal disorder (bvFTD) according to Rascovsky criteria (2011) or patients with phénocopy frontotemporal dementia (phFTD) who fulfill criteria for possible bvFTD and have no imaging abnormalities or patients with frontal variant of Alzheimer disease according to Ossenkopele criteria (2022), or patient with bipolar disorder according to CIM 10 criteria

• Score for Mini-mental state examination = 18

• Patient with caregiver who has who has known him/her in the 10 years preceding the disease onset.

• Patient and caregiver consents (no opposition)

Exclusion Criteria :

• Patient with no caregiver

• Pregnant or breast feeding women

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Bipolar Disorder
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

Other:
• Submission of the NEO-PI-3 questionnaire
The questionnaire contains 240 statements. For each statement, the patient chooses the answer that best corresponds to their choice (FD: strongly disagree - D: disagree - N: neutral - A: agree - FA: strongly agree).
• Submission of the Interpersonal Reactivity Index questionnaire (IRI)
The test assesses two cognitive and two affective components of empathy that influence each other and affect attitudes and behaviors toward others.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premorbid personality traits	Premorbid personality traits will be assessed by the NEO- NEO Personality Inventory-3 (NEO-PI-3). The NEO PI-3 measures the five major domains of personality: Neuroticism, Extraversion, Openness to experience, Conscientiousness and Agreeableness. Each domain is defined by 6 facets. NEOPI-3 includes 240 items and responses are made on a 5-point Likert -type scale ranging from strongly Disagree to strongly agree. The NEOPI 3 will be completed by a caregiver who has known the patient in the 10 years preceding the disease onset.	Baseline
Secondary	Interpersonal Reactivity Index (IRI)	IRI is a 28-item questionnaire measuring 4 aspects of empathy : perspective-taking, fantasy, empathic concern, personal distress. Each answer is rated from 1 (does not describe me well) to 5 (describes me very well).	Baseline