NCT04820946

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2.9 years

First QC Date

March 25, 2021

Last Update Submit

April 11, 2023

Conditions

Keywords

Disruptive Mood Dysregulation Disorderprognosis factorsnatural coursesuicidal behaviorsactigraphypediatric depressive disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

various episodic mood disturbances patient group

A group of patients with various episodic mood disturbances was used as a clinical case control group.

Disruptive Mood Dysregulation Disorder (DMDD) patient group

DMDD patients referred to the hospital for suicidal behaviors between 2013 and 2018 in terms of diagnostic stability, psychiatric comorbidity, and psychosocial factors.

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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"

You may not qualify if:

  • No affiliation to a social security service
  • Persons deprived of their liberty as stipulated in article L.1121-6 of the Public Health Code

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 29, 2021

Study Start

March 24, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations