Irritable MoodRESISTNCT05528926
RESist Against Irritability Superiority Trial
A study testing Non-Violent Resistance, Parent Management Training and Treatment As Usual in people with Irritable Mood, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Irritability is defined as developmentally inappropriate proneness to anger. Irritability is a symptom of several mental health conditions in children and adolescents such as attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder (CD), depressive disorders, anxiety… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Irritable Mood
- What is being tested?
- Non-Violent Resistance, Parent Management Training and Treatment As Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2023to 1 Sep 2026
- Phase
- Interventional
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subject between 6 and 15 years-old.
- Express informed consent f by at least one of the parents or legal representative, and oral consent of the child.
- A confirmed K-SADS DSM-5 diagnosis of ADHD, ODD, CD, mood/anxiety disorder or DMDD, or a clinical diagnosis of IED. The request of a concomitant mental disorder allows to restrict this intervention to a clinical population.
- A Parental-rated ARI total score of 4 or above at baseline.
- A Clinical Global Impression-Severity score (CGI-S) of 4 or above (=at least moderately ill).
- Persistence of irritability symptoms 6 month or above at baseline (this avoids including children with transitory irritability).
- stable treatment regimen (pharmacological and non-pharmacological) for 2 weeks prior to inclusion and during the trial
- RESIST-QUAL : Same inclusion criteria as above with specific informed consent form signed by the participating parent.
Who cannot join
- Unavailability of parents or legal representative during the study period.
- Subjects with a DSM-5 diagnosis (clinical presentation or history) that is consistent with Schizophrenia or psychotic disorders or acute manic episodes.
- Diagnosis of Autism Spectrum Disorder (ASD) in patients who are non-verbal and with IQ lower than 70.
- Known or estimated IQ<70 or clinical diagnosis of intellectual disability.
- Subjects with severe irritability that are better accounted for by another factor, e.g.: general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use), as determined by the clinical judgment of the investigator, or related to child abuse and/or neglect.
- absence of informed consent give by at least one of the parents or legal representatives, and oral consent of the child
Show all 9Show fewer
- inability to speak and comprehend French
- deemed unable to comply with the trial protocol
- participation in a structured parent program during the last 6 months
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH of Montpellier
Montpellier, 34295
Diane Pr PURPER-OUAKIL, 04.67.33.60.09 ext. +33, d-purper_ouakil@chu-montpellier.fr
About this study
Official title: Parent Training for the Treatment of Irritability in Children and Adolescents: a Multisite Randomized Controlled, 3-parallel-group, Evaluator-blinded, Superiority Trial
Irritability is defined as developmentally inappropriate proneness to anger. Irritability is a symptom of several mental health conditions in children and adolescents such as attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder (CD), depressive disorders, anxiety disorders.Irritability has been associated with poor functional outcomes across the lifespan and was found to be specifically associated with concurrent and longitudinal emotional disorders, suicidality and impaired academic and socio-professional functioning. Children with high irritability also have distinct physiological profiles with hyper-reactivity to stress and perceived threats.
Despite the high prevalence and health issues related to irritability, there is little treatment research on this topic. Developing evidence-based non-pharmacological treatment options for children suffering from severe, chronic irritability is therefore a particularly important target for clinical research.
Read the detailed description
Irritability is defined as developmentally inappropriate proneness to anger. Irritability is a symptom of several mental health conditions in children and adolescents such as attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder (CD), depressive disorders, anxiety disorders. Both tonic (e.g. negative quality of mood) and phasic (e.g. temper outbursts) irritability are criteria of the DSM-5 Disruptive Mood Dysregulation Disorder and the World Health Organization has considered the addition of a specifier to indicate whether ODD presents with chronic irritability and anger in the revision of the International Classification of Disease.
Irritability has been associated with poor functional outcomes across the lifespan and was found to be specifically associated with concurrent and longitudinal emotional disorders, suicidality and impaired academic and socio-professional functioning. Children with high irritability also have distinct physiological profiles with hyper-reactivity to stress and perceived threats.
Irritability is included in the negative valence system of RDoC as "frustrative non-reward". According to this neuroscience-based classification, irritability is an excessive response of an individual faced with the impossibility to achieve an expected goal and has been linked to dysregulations of the autonomic nervous system and the reward network. Another pathophysiological line of research conceptualizes irritability as an aberrant response to threat (e.g. irritable individuals may attack more rapidly and in broader contexts).
Despite the high prevalence and health issues related to irritability, there is little treatment research on this topic. Developing evidence-based non-pharmacological treatment options for children suffering from severe, chronic irritability is therefore a particularly important target for clinical research. One of the first steps in achieving this goal includes testing new therapies against extant interventions. Parent training programs decrease aggressive behaviours in children and are therefore good candidates for the improvement of irritability. Low parental warmth, lack of positive parental emotion socialization and high parental Expressed Emotions have been linked with irritability in children and could therefore be targeted in parental programs.
Research on the biological and psychological mechanisms mediating irritability is also needed to further improve specificity of therapeutic actions.
The project includes two ancyllary studies : RESIST-EXP and RESIST-QUAL.
- RESIST-EXP: Investigate improvement of irritability in both programs throughout emotional testing while collecting ANS functioning measurements.
- RESIST-QUAL: A qualitative interview planned after treatment completion with parents from both parent programme groups.
- Conditions
- Irritable Mood
- Being tested
- Non-Violent Resistance, Parent Management Training, Treatment As Usual
- Keywords
- Irritability, Parent Management Training (PMT), Non-Violent Resistance (NVR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Violent ResistanceOther
Also called NVR program
The program's core features are parental self-control and emotional support. In the NVR program, parents recruit supporters to help them deal with their children's problematic behaviours. Developing emotional control means that the parent opposes non-violent resistance to his child's behaviour, not escalating the explosive situation.
10 sessions (5 sessions per day for 2 consecutive days and two booster sessions at M1 and M3 after completion).
Parent Management TrainingOther
Also called PMT program
The gold-standard treatment for disruptive behaviour disorder in children and adolescents. The objective is to train parents to cope with the difficult situations they encounter, to teach them effective control strategies that are coherent and adapted to the 'deviant' behaviour of their children to reduce the intensity of events and their repercussions within the family.
10 sessions (5 sessions per day for 2 consecutive days and two booster sessions at M1 and M3 after completion).
Also called TAU
The TAU group receives non-pharmacological and pharmacological therapies as usually provided in the participating centres but without having had a structured parent program in the last 6 months assessed at baseline, M1 and M3.
| Study group | Role | What they receive |
|---|---|---|
| Non-Violent Resistance (NVR) program | Other | The Non-Violent Resistance (NVR) parent group-format program has been designed to develop a positive form of authority based on parental presence, a parental support network, strategies of nonviolent responses which avoid escalation and reconciliation gestures. Receives: Other: Non-Violent Resistance |
| Parent Management Training (PMT) program based on Barkley's program for defiant children | Other | The Parent Management Treatment (PMT) program is an evidence-based treatment for disruptive behaviour disorder in which the child's social environment is modified according to principles of operant conditioning and contingency management. The parental response to the child's behaviour increases or decreases the likelihood of targeted behaviour. Receives: Other: Parent Management Training |
| Treatment as usual (TAU) | Other | The TAU group receives non-pharmacological and pharmacological therapies as usually provided in the participating centres but without having had a structured parent program. Receives: Drug: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline level that measure pleasure and arousal
Change from baseline at 3 months after completion of the program of the Clinician-rated Affective Rating Scale (CL-ARI) assessed by blinded evaluators.
This scale gives a range of possible scores from 0 to 12, with frequency and duration of temper outbursts quantified across three different levels of severity: mild, moderate and severe the higher the score.
Measured: After 3 months follow-up
Secondary outcomes (13)
Secondary efficacy endpoint at 1-month follow-up
Change from baseline at 1 month after completion of the program of the Clinician-rated Affective Rating Scale (CL-ARI) by blinded evaluators.
This scale gives a range of possible scores from 0 to 12, with frequency and duration of temper outbursts quantified across three different levels of severity: mild, moderate and severe the higher the score.
Measured: After 1 month follow-up
Secondary efficacy endpoints at 1 and 3-month follow-up
Clinical Global Impression Improvement (CGI-I) scale from 1 to 7. the CGI-I 7-point scale to rate the patients' total improvement based on comparison with their baseline assessment from 1 = very much improved to 7 = very much worse.
Measured: Between 1 and 3-month follow-up
Secondary efficacy endpoints at 1 and 3-month follow-up
Change from baseline in the Parenting and Familial Adjustement Scale (PAFAS)
Measured: Between 1 and 3-month follow-up
Secondary efficacy endpoints at 1 and 3-month follow-up
Change from baseline in Parent-rated ARI and Child-rated Cranky thermometers
Measured: Between 1 and 3-month follow-up
Exploratory efficacy endpoints and putative moderators and mediators.
Initial score and change from baseline in expressed emotions and reflexivity during the online five-minute speech sample (FMSS) at 3 months
Measured: After 3-month follow-up
Exploratory efficacy endpoints and putative moderators and mediators.
Initial score and change from baseline in The Child Behavior Checklist for Ages 6-18 (CBCL 6-18) (parent-rated)
Measured: At 1 month and 3 months follow-up
Exploratory efficacy endpoints and putative moderators and mediators.
Initial scores of personality dimensions assessed with Hierarchical Personality Inventory for Children (HiPIC)
Measured: After 3 months follow-up
Exploratory efficacy endpoints and putative moderating and mediating variables.
Initial score and change from baseline in parental expressed emotions and reflexivity rated with the Five-Minute Speech Sample (FMSS).
The FMSS is scored by considering the following 5 categories: initial statement, relationship, criticism, dissatisfaction and emotional overinvolvement.
- Initial statement is scored as positive, neutral, or negative
- Relationship is scored as positive, neutral, or negative
- Criticism is scored by a frequency count used to score the number of criticisms present in the language sample.
- Dissatisfaction is scored as present or absent
- Emotional overinvolvement is based on the following 5 categories:
- selfsacrificing overprotective behavior ,
- emotional display ,
- statements of attitude,
- excessive detail and/or irrelevant information about the past,
- excessive praise.
Measured: At 3 months follow-up
Endpoints of the ancillary study: RESIST-EXP
These parameters will be measured on a sub-group of patients by a wristband "E4 wristband" permitting real-time physiological data acquisition:
Blood Volume Pulse (BVP) in L/min
Measured: At baseline ans at 3 months follow-up
Endpoints of the ancillary study: RESIST-EXP
These parameters will be measured on a sub-group of patients by a wristband "E4 wristband" permitting real-time physiological data acquisition:
Motor Activity (in steps/day)
Measured: At baseline ans at 3 months follow-up
Endpoints of the ancillary study: RESIST-EXP
These parameters will be measured on a sub-group of patients by a wristband "E4 wristband" permitting real-time physiological data acquisition:
Skin conductance (in Micro Siemens)
Measured: At baseline ans at 3 months follow-up
Endpoints of the ancillary study: RESIST-EXP
These parameters will be measured on a sub-group of patients by a wristband "E4 wristband" permitting real-time physiological data acquisition:
Skin temperature (in °C)
Measured: At baseline ans at 3 months follow-up
Endpoints of the ancillary study: RESIST-QUAL
Acceptability (questionnaire for all parents and qualitative interview in a subsample
Measured: After 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start25 Apr 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable MoodStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 parallel groups to compare: * Non-Violent Resistance parent training (NVR) * Parent Management Training (PMT) * Treatment As Usual (TAU)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528926
- Sponsor's protocol ID
- RECHMPL20_0038
- Acronym
- RESIST
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fongaro E, Picot MC, Stringaris A, Belloc C, Verissimo AS, Franc N, Purper-Ouakil D. Parent training for the treatment of irritability in children and adolescents: a multisite randomized controlled, 3-parallel-group, evaluator-blinded, superiority trial. BMC Psychol. 2022 Nov 22;10(1):273. doi: 10.1186/s40359-022-00984-5.
PubMed 36414963
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Training for the Treatment of Irritability in Children and Adolescents: a Multisite Randomized Controlled, 3-parallel-group, Evaluator-blinded, Superiority Trial
- ClinicalTrials.gov ID
- NCT05528926
- Acronym / sponsor ID
- RESIST / RECHMPL20_0038
- Conditions
- Irritable Mood
- Keywords
- Irritability, Parent Management Training (PMT), Non-Violent Resistance (NVR)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Sep 2022 (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.
Irritability is defined as developmentally inappropriate proneness to anger. Irritability is a symptom of several mental health conditions in children and adolescents such as attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder (CD), depressive disorders, anxiety disorders.Irritability has been associated with poor functional outcomes across the lifespan and was found to be specifically associated with concurrent and longitudinal emotional disorders, suicidality and impaired academic and socio-professional functioning. Children with high irritability also have distinct physiological profiles with hyper-reactivity to stress and perceived threats.
Despite the high prevalence and health issues related to irritability, there is little treatment research on this topic. Developing evidence-based non-pharmacological treatment options for children suffering from severe, chronic irritability is therefore a particularly important target for clinical research.
Detailed description
Irritability is defined as developmentally inappropriate proneness to anger. Irritability is a symptom of several mental health conditions in children and adolescents such as attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder (CD), depressive disorders, anxiety disorders. Both tonic (e.g. negative quality of mood) and phasic (e.g. temper outbursts) irritability are criteria of the DSM-5 Disruptive Mood Dysregulation Disorder and the World Health Organization has considered the addition of a specifier to indicate whether ODD presents with chronic irritability and anger in the revision of the International Classification of Disease.
Irritability has been associated with poor functional outcomes across the lifespan and was found to be specifically associated with concurrent and longitudinal emotional disorders, suicidality and impaired academic and socio-professional functioning. Children with high irritability also have distinct physiological profiles with hyper-reactivity to stress and perceived threats.
Irritability is included in the negative valence system of RDoC as "frustrative non-reward". According to this neuroscience-based classification, irritability is an excessive response of an individual faced with the impossibility to achieve an expected goal and has been linked to dysregulations of the autonomic nervous system and the reward network. Another pathophysiological line of research conceptualizes irritability as an aberrant response to threat (e.g. irritable individuals may attack more rapidly and in broader contexts).
Despite the high prevalence and health issues related to irritability, there is little treatment research on this topic. Developing evidence-based non-pharmacological treatment options for children suffering from severe, chronic irritability is therefore a particularly important target for clinical research. One of the first steps in achieving this goal includes testing new therapies against extant interventions. Parent training programs decrease aggressive behaviours in children and are therefore good candidates for the improvement of irritability. Low parental warmth, lack of positive parental emotion socialization and high parental Expressed Emotions have been linked with irritability in children and could therefore be targeted in parental programs.
Research on the biological and psychological mechanisms mediating irritability is also needed to further improve specificity of therapeutic actions.
The project includes two ancyllary studies : RESIST-EXP and RESIST-QUAL.
- RESIST-EXP: Investigate improvement of irritability in both programs throughout emotional testing while collecting ANS functioning measurements.
- RESIST-QUAL: A qualitative interview planned after treatment completion with parents from both parent programme groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 parallel groups to compare: * Non-Violent Resistance parent training (NVR) * Parent Management Training (PMT) * Treatment As Usual (TAU)
| Arm | Type | Receives |
|---|---|---|
| Non-Violent Resistance (NVR) program | Other | Other: Non-Violent ResistanceThe Non-Violent Resistance (NVR) parent group-format program has been designed to develop a positive form of authority based on parental presence, a parental support network, strategies of nonviolent responses which avoid escalation and reconciliation gestures. |
| Parent Management Training (PMT) program based on Barkley's program for defiant children | Other | Other: Parent Management TrainingThe Parent Management Treatment (PMT) program is an evidence-based treatment for disruptive behaviour disorder in which the child's social environment is modified according to principles of operant conditioning and contingency management. The parental response to the child's behaviour increases or decreases the likelihood of targeted behaviour. |
| Treatment as usual (TAU) | Other | Drug: Treatment As UsualThe TAU group receives non-pharmacological and pharmacological therapies as usually provided in the participating centres but without having had a structured parent program. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male and female subject between 6 and 15 years-old.
- Express informed consent f by at least one of the parents or legal representative, and oral consent of the child.
- A confirmed K-SADS DSM-5 diagnosis of ADHD, ODD, CD, mood/anxiety disorder or DMDD, or a clinical diagnosis of IED. The request of a concomitant mental disorder allows to restrict this intervention to a clinical population.
- A Parental-rated ARI total score of 4 or above at baseline.
- A Clinical Global Impression-Severity score (CGI-S) of 4 or above (=at least moderately ill).
Key exclusion criteria (9 listed)
- Unavailability of parents or legal representative during the study period.
- Subjects with a DSM-5 diagnosis (clinical presentation or history) that is consistent with Schizophrenia or psychotic disorders or acute manic episodes.
- Diagnosis of Autism Spectrum Disorder (ASD) in patients who are non-verbal and with IQ lower than 70.
- Known or estimated IQ<70 or clinical diagnosis of intellectual disability.
- Subjects with severe irritability that are better accounted for by another factor, e.g.: general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use), as determined by the clinical judgment of the investigator, or related to child abuse and/or neglect.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Violent ResistanceAlso: NVR programThe program's core features are parental self-control and emotional support. In the NVR program, parents recruit supporters to help them deal with their children's problematic behaviours. Developing emotional control means that the parent opposes non-violent resistance to his child's behaviour, not escalating the explosive situation. 10 sessions (5 sessions per day for 2 consecutive days and two booster sessions at M1 and M3 after completion). | Other | Non-Violent Resistance (NVR) program |
| Parent Management TrainingAlso: PMT programThe gold-standard treatment for disruptive behaviour disorder in children and adolescents. The objective is to train parents to cope with the difficult situations they encounter, to teach them effective control strategies that are coherent and adapted to the 'deviant' behaviour of their children to reduce the intensity of events and their repercussions within the family. 10 sessions (5 sessions per day for 2 consecutive days and two booster sessions at M1 and M3 after completion). | Other | Parent Management Training (PMT) program based on Barkley's program for defiant children |
| Treatment As UsualAlso: TAUThe TAU group receives non-pharmacological and pharmacological therapies as usually provided in the participating centres but without having had a structured parent program in the last 6 months assessed at baseline, M1 and M3. | Drug | Treatment as usual (TAU) |
Primary outcome
Change from baseline level that measure pleasure and arousal
Time frame: After 3 months follow-up
Change from baseline at 3 months after completion of the program of the Clinician-rated Affective Rating Scale (CL-ARI) assessed by blinded evaluators. This scale gives a range of possible scores from 0 to 12, with frequency and duration of temper outbursts quantified across three different levels of severity: mild, moderate and severe the higher the score.
13 secondary outcomes
Secondary efficacy endpoint at 1-month follow-up
Time frame: After 1 month follow-up
Secondary efficacy endpoints at 1 and 3-month follow-up
Time frame: Between 1 and 3-month follow-up
Secondary efficacy endpoints at 1 and 3-month follow-up
Time frame: Between 1 and 3-month follow-up
Secondary efficacy endpoints at 1 and 3-month follow-up
Time frame: Between 1 and 3-month follow-up
Exploratory efficacy endpoints and putative moderators and mediators.
Time frame: After 3-month follow-up
Exploratory efficacy endpoints and putative moderators and mediators.
Time frame: At 1 month and 3 months follow-up
Exploratory efficacy endpoints and putative moderators and mediators.
Time frame: After 3 months follow-up
Exploratory efficacy endpoints and putative moderating and mediating variables.
Time frame: At 3 months follow-up
Endpoints of the ancillary study: RESIST-EXP
Time frame: At baseline ans at 3 months follow-up
Endpoints of the ancillary study: RESIST-EXP
Time frame: At baseline ans at 3 months follow-up
Endpoints of the ancillary study: RESIST-EXP
Time frame: At baseline ans at 3 months follow-up
Endpoints of the ancillary study: RESIST-EXP
Time frame: At baseline ans at 3 months follow-up
Endpoints of the ancillary study: RESIST-QUAL
Time frame: After 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 36414963Fongaro E, Picot MC, Stringaris A, Belloc C, Verissimo AS, Franc N, Purper-Ouakil D. Parent training for the treatment of irritability in children and adolescents: a multisite randomized controlled, 3-parallel-group, evaluator-blinded, superiority trial. BMC Psychol. 2022 Nov 22;10(1):273. doi: 10.1186/s40359-022-00984-5.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Violent Resistance, Parent Management Training and Treatment As Usual in people with Irritable Mood, run by University Hospital, Montpellier 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diane Pr PURPER-OUAKIL (04.67.33.60.09 ext. +33, d-purper_ouakil@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline level that measure pleasure and arousal (time frame: After 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05528926, which also lists 1 linked publication.
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 14 Aug 2023.