Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01591564
NCT01591564CompletedNot Applicable

Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

Johns Hopkins University2 sites in 1 country3 target enrollmentStarted: July 2012Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3
Locations
2
Primary Endpoint
Retention rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Retention rate

Time Frame: 20 weeks

We are assessing the feasibility and acceptability of IPT-SMD in anticipation of conducting a larger trial.

Secondary Outcomes

  • Clinical Global Impressions Scale CGI-I (SMD)(20 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leslie Miller, M.D.

Assistant Professor

Johns Hopkins University

Study Sites (2)

Loading locations...

Similar Trials

Completed
Not Applicable
Interpersonal Psychotherapy for Youth With Severe Mood DysregulationSevere Mood Dysregulation
NCT01962623Johns Hopkins University31
Completed
Not Applicable
IPT-A for Adolescents With PTSD SymptomsPTSD
NCT03795818New York State Psychiatric Institute9
Completed
Phase 1
Interpersonal Psychotherapy for Depressed Adolescents and ParentsMajor DepressionDysthymic DisorderAdjustment DisordersDepressive Disorder Not Otherwise Specified
NCT00619411New York State Psychiatric Institute10
Recruiting
Not Applicable
Interpersonal Psychotherapy for Adolescents and Young AdultsMajor Depression
NCT05575960Linnaeus University60
Completed
Not Applicable
Emotion and Symptom-focused Engagement for Caregivers (EASE-CG) Pilot StudyLeukemia, Acute
NCT05236296University Health Network, Toronto40