Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

Johns Hopkins University1 site in 1 country3 target enrollmentJuly 2012

ConditionsSevere Mood Dysregulation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Severe Mood Dysregulation
Sponsor: Johns Hopkins University
Enrollment: 3
Locations: 1
Primary Endpoint: Retention rate
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the feasibility and acceptability of an utilizing an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD).

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-SMD intervention will have overall improvement in SMD symptoms.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

December 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Principal Investigator

Leslie Miller, M.D.

Assistant Professor

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

•Male and female subjects, ages 13 to 17 years, who meet criteria for severe mood dysregulation as defined by NIMH criteria.
•Subject has an estimated IQ \>70 on the Kaufman Brief Intelligence Test (KBIT-2)
•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.
•Participants must be on the same dose of any prescribed medication for 4 weeks prior to randomization.
•Children's Global Assessment Scale (CGAS) ≤ 60

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 co-morbidity 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).
•Pregnant females.
•Primary caretaker does not speak English