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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04820946
Other study ID # PI2020_843_0013
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 24, 2021
Est. completion date March 2024

Study information

Verified date April 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Xavier BENAROUS, MD
Phone 03.22.08.76.30
Email benarous.xavier@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Little is known about the natural course and prognosis factors of inpatients and outpatients with Disruptive Mood Dysregulation Disorder (DMDD). The investigators conducted a cross-sectional study to determine the evolution of a sample of DMDD patients referred to the hospital for suicidal behaviors between 2013 and 2018 in terms of diagnostic stability, psychiatric comorbidity, and psychosocial factors. A group of patients with various episodic mood disturbances was used as a clinical case control group. In addition to change in DMDD symptoms across time, the investigators examined the onset and persistence of psychiatric comorbidity using the KIDDIE-SADS PL and suicidal behaviors using the Colombia Suicidality Severity Rating Scale. The investigators also examined the persistence of depressive symptoms using the Beck Depression Inventory (BDI-II), the persistence of emotional lability (Affective Lability Scale-18), borderline traits (Abbreviated Diagnostic of Inventory Borderline). Socio-demographic, clinical features and actigraphy-measured sleep characteristics determined between 2013 and 2018 were used to predict the evolution of the DMDD patients and the clinical control group.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 25 Years
Eligibility Inclusion Criteria: - Boys and girls between 10 and 25-year-old - patients who had been referred to the university hospital of Amiens for suicidal behaviors between 2013 and 2018 - patients who participated to the study "Clinical and actigraphy-measured profiles of inpatient youths with suicidal behavior: exploration of the severe mood dysregulation" Exclusion Criteria: - No affiliation to a social security service - Persons deprived of their liberty as stipulated in article L.1121-6 of the Public Health Code

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic evolution toward an other psychiatric disorder. The evolution toward another psychiatric disorder would be examined using the semi-structured interview KIDDIE-SADS and the Ab-DIB to examine borderline traits.
The K-SADS is a semi-structured interview to measure current and past symptoms of mood, anxiety, psychotic, and disruptive behavior disorders in children ages 6-18 years old.
(Ab-DIB) as a screening measure of borderline psychopathology in an adolescent clinical population.
one day
Primary persistence of a full-blown DMDD diagnostic The persistence of a full-blown DMDD diagnostic would be defined using the DSM-5 criteria. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) is the 2013 update to the Diagnostic and Statistical Manual of Mental Disorders, the taxonomic and diagnostic tool published by the American Psychiatric Association. one day
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