Disruptive Mood Dysregulation DisorderACTIHUMEURp3NCT04820946
Evolution of DMDD Children and Adolescent
An observational study of Disruptive Mood Dysregulation Disorder and Prognosis Factors, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Disruptive Mood Dysregulation Disorder, Prognosis Factors, Suicidal Behaviors
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2022to 9 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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"
Who cannot join
- No affiliation to a social security service
- Persons deprived of their liberty as stipulated in article L.1121-6 of the Public Health Code
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Children and Adolescents With Disruptive Mood Dysregulation Disorder Refereed to Hospital for Suicidal Behavior After Three Year: Diagnostic Stability, Psychiatric Comorbidity, Psychosocial Functioning, Identification of Clinical and Actigraphy-measured Prognosis Factors
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.
- Keywords
- Disruptive Mood Dysregulation Disorder, prognosis factors, natural course, suicidal behaviors, actigraphy, pediatric depressive disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start16 Nov 2022
- Primary completion9 Mar 2026
- Study completion9 Mar 2026
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive Mood Dysregulation 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820946
- Sponsor's protocol ID
- PI2020_843_0013
- Acronym
- ACTIHUMEURp3
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2021
- Last updated
- 25 Jun 2026
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Children and Adolescents With Disruptive Mood Dysregulation Disorder Refereed to Hospital for Suicidal Behavior After Three Year: Diagnostic Stability, Psychiatric Comorbidity, Psychosocial Functioning, Identification of Clinical and Actigraphy-measured Prognosis Factors
- ClinicalTrials.gov ID
- NCT04820946
- Acronym / sponsor ID
- ACTIHUMEURp3 / PI2020_843_0013
- Keywords
- Disruptive Mood Dysregulation Disorder, prognosis factors, natural course, suicidal behaviors, actigraphy, pediatric depressive disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 29 Mar 2021 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (2 listed)
- No affiliation to a social security service
- Persons deprived of their liberty as stipulated in article L.1121-6 of the Public Health Code
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic evolution toward an other psychiatric disorder.
Time frame: one day
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.
persistence of a full-blown DMDD diagnostic
Time frame: one day
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.
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disruptive Mood Dysregulation Disorder and Prognosis Factors, run by Centre Hospitalier Universitaire, Amiens 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 Jun 2026. 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?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic evolution toward an other psychiatric disorder. (time frame: one day). The study lists 2 primary outcomes in all. 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 25 Jun 2026.