Clinical trial NCT01962623: Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation
Official title: Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation- Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Mood Dysregulation
Keywords: Severe Mood Dysregulation
Mood Disorders
Irritability
Disruptive Mood Dysregulation Disorder
Interpersonal Psychotherapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-10-14
Enrollment: 31
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Retention rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Clinical Global Impressions Scale for SMD/DMDD (CGI-SMD/DMDD)
timeFrame: 24 weeks
measure: Satisfaction
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Leslie Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: