Severe Mood DysregulationNCT01962623
Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation
A study testing IPT-MBD in people with Severe Mood Dysregulation, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and acceptability of utilizing an adapted form (i.e. IPT-MBD) of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD) or disruptive mood dysregulation disorder (DMDD). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Severe Mood Dysregulation
- What is being tested?
- IPT-MBD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Oct 2015
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects, ages 12 to 17 years, who meet criteria for severe mood dysregulation (SMD) as defined by NIMH criteria or for disruptive mood dysregulation disorder (DMDD).
- Subject has an estimated IQ >70 on the Kaufman Brief Intelligence Test (KBIT-
- Subjects will have continuously resided with a legal guardian who has known the adolescent well for at least one year before study entry and is legally able to sign the consent form.
- Children's Global Assessment Scale (CGAS) ≤ 60
- CGI-S (SMD) ≥ 4
- Participant and guardian must agree to have therapy sessions audiotaped for training purposes.
Who cannot join
- Subject poses a significant risk for dangerousness to self or others. Risk will be determined by clinical history, clinical diagnostic interview and KSADS-PL interview of parent and patient by clinician.
- Subject suffers from a concomitant medical or psychiatric comorbidity that makes this study protocol inadvisable (either the treatment is contraindicated or the disorder is not the primary focus of treatment).
- Subject meets DSM-IV criteria for current alcohol or substance dependence or current use (defined as the past 4 weeks).
- Primary caretaker does not speak English or is not capable of completing study measures.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation- Randomized Trial
The purpose of this study is to determine the feasibility and acceptability of utilizing an adapted form (i.e. IPT-MBD) of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD) or disruptive mood dysregulation disorder (DMDD).
The investigators hypothesize that retention rates will be >80%, satisfaction scores will average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT intervention will have overall improvement in SMD/DMDD symptoms.
Read the detailed description
This research is being done to learn more about how to help teenagers with a sad or angry mood, and emotional responses out of proportion to what would be expected in a situation. Together these symptoms are called Severe Mood Dysregulation (SMD), a research diagnosis, or disruptive mood dysregulation disorder (DMDD), a newer clinical diagnosis. Currently, there is no standard treatment for teens that have SMD/DMDD. These teens usually receive medication and some type of talk therapy. This research is being done to compare two types of talk therapy to see which is most effective in helping teens with SMD/DMDD. Investigators will compare treatment as usual (TAU) with Interpersonal Psychotherapy for Youth with Mood and Behavior Dysregulation (IPT-MBD). Investigators do not know if TAU and IPT-MBD work just as well, or if one is better than the other. When this study is over, investigators hope there will be a better idea of how to study treatments for teens with SMD/DMDD.
For those participants who receive IPT-MBD, are prescribed an antipsychotic, and have significant improvement in symptoms, investigators will gradually taper the antipsychotic dose.
- Conditions
- Severe Mood Dysregulation
- Being tested
- IPT-MBD
- Keywords
- Severe Mood Dysregulation, Mood Disorders, Irritability, Disruptive Mood Dysregulation Disorder, Interpersonal Psychotherapy
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPT-MBDOther
Also called IPT for Mood and Behavior Dysregulation
IPT-MBD is a modified form of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), which emphasizes building skills in managing relationships, helping with problem solving, and strengthening communication skills.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Participants who are not randomly assigned to the IPT-MBD group will continue with treatment at usual, which is considered routine care. Receives: Other: IPT-MBD |
| IPT-MBD | Other | Weekly Interpersonal Therapy for SMD/DMDD (IPT-MBD) sessions, which emphasizes building skills in managing relationships, helping with problem solving, strengthening communication skills and other skills. Receives: Other: IPT-MBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
To describe/assess feasibility of IPT-MBD, investigators will look at ease of recruitment and retention rate goal of at least 80%. Investigators will collect data on the number of subjects recruited, enrolled, and who followed the protocol for 24 weeks. Investigators will comment on adherence to the overall study, as well as to specific treatment visits.
Measured: 24 weeks
Secondary outcomes (2)
Clinical Global Impressions Scale for SMD/DMDD (CGI-SMD/DMDD)
Investigators will utilize the Clinical Global Impressions Scale for Global Improvement (CGI-I) and Severity of Illness (CGI-S) to measure improvement in SMD/DMDD symptoms and to assess the effectiveness of IPT-MBD on the severity of SMD/DMDD symptoms in youth with SMD/DMDD.
Measured: 24 weeks
Satisfaction
To assess the feasibility and acceptability of a 24-week psychosocial treatment intervention for youth with SMD/DMDD, investigators will compare satisfaction questionnaires between treatment arms.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mood DysregulationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Leslie Miller, M.D., Johns Hopkins University
- Investigators
- Leslie Miller, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962623
- Sponsor's protocol ID
- NA_00083893
- Other IDs
- K23MH090246
- Status last verified
- May 2017
- First submitted
- 10 Oct 2013
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation- Randomized Trial
- ClinicalTrials.gov ID
- NCT01962623
- Acronym / sponsor ID
- NA_00083893
- Conditions
- Severe Mood Dysregulation
- Keywords
- Severe Mood Dysregulation, Mood Disorders, Irritability, Disruptive Mood Dysregulation Disorder, Interpersonal Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Oct 2013 (estimated)
- 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.
The purpose of this study is to determine the feasibility and acceptability of utilizing an adapted form (i.e. IPT-MBD) of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD) or disruptive mood dysregulation disorder (DMDD).
The investigators hypothesize that retention rates will be >80%, satisfaction scores will average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT intervention will have overall improvement in SMD/DMDD symptoms.
Detailed description
This research is being done to learn more about how to help teenagers with a sad or angry mood, and emotional responses out of proportion to what would be expected in a situation. Together these symptoms are called Severe Mood Dysregulation (SMD), a research diagnosis, or disruptive mood dysregulation disorder (DMDD), a newer clinical diagnosis. Currently, there is no standard treatment for teens that have SMD/DMDD. These teens usually receive medication and some type of talk therapy. This research is being done to compare two types of talk therapy to see which is most effective in helping teens with SMD/DMDD. Investigators will compare treatment as usual (TAU) with Interpersonal Psychotherapy for Youth with Mood and Behavior Dysregulation (IPT-MBD). Investigators do not know if TAU and IPT-MBD work just as well, or if one is better than the other. When this study is over, investigators hope there will be a better idea of how to study treatments for teens with SMD/DMDD.
For those participants who receive IPT-MBD, are prescribed an antipsychotic, and have significant improvement in symptoms, investigators will gradually taper the antipsychotic dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Other: IPT-MBDParticipants who are not randomly assigned to the IPT-MBD group will continue with treatment at usual, which is considered routine care. |
| IPT-MBD | Other | Other: IPT-MBDWeekly Interpersonal Therapy for SMD/DMDD (IPT-MBD) sessions, which emphasizes building skills in managing relationships, helping with problem solving, strengthening communication skills and other skills. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female subjects, ages 12 to 17 years, who meet criteria for severe mood dysregulation (SMD) as defined by NIMH criteria or for disruptive mood dysregulation disorder (DMDD).
- Subject has an estimated IQ >70 on the Kaufman Brief Intelligence Test (KBIT-
- Subjects will have continuously resided with a legal guardian who has known the adolescent well for at least one year before study entry and is legally able to sign the consent form.
- Children's Global Assessment Scale (CGAS) ≤ 60
- CGI-S (SMD) ≥ 4
Key exclusion criteria (5 listed)
- Subject poses a significant risk for dangerousness to self or others. Risk will be determined by clinical history, clinical diagnostic interview and KSADS-PL interview of parent and patient by clinician.
- Subject suffers from a concomitant medical or psychiatric comorbidity that makes this study protocol inadvisable (either the treatment is contraindicated or the disorder is not the primary focus of treatment).
- Subject meets DSM-IV criteria for current alcohol or substance dependence or current use (defined as the past 4 weeks).
- Primary caretaker does not speak English or is not capable of completing study measures.
- Pregnant females.
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 |
|---|---|---|
| IPT-MBDAlso: IPT for Mood and Behavior DysregulationIPT-MBD is a modified form of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), which emphasizes building skills in managing relationships, helping with problem solving, and strengthening communication skills. | Other | IPT-MBD, Treatment as Usual (TAU) |
Primary outcome
Retention rate
Time frame: 24 weeks
To describe/assess feasibility of IPT-MBD, investigators will look at ease of recruitment and retention rate goal of at least 80%. Investigators will collect data on the number of subjects recruited, enrolled, and who followed the protocol for 24 weeks. Investigators will comment on adherence to the overall study, as well as to specific treatment visits.
2 secondary outcomes
Clinical Global Impressions Scale for SMD/DMDD (CGI-SMD/DMDD)
Time frame: 24 weeks
Satisfaction
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
Related trials for Severe Mood Dysregulation
RecruitingObservational study
Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder
Mood Disorder
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.
Leslie Miller, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPT-MBD in people with Severe Mood Dysregulation, run by Johns Hopkins University at 1 site in United States.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 24 May 2017. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retention rate (time frame: 24 weeks). 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 24 May 2017.