Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

This study is currently recruiting participants.
Verified August 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leslie Miller, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01591564
First received: May 2, 2012
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Severe Mood Dysregulation
Behavioral: Interpersonal Psychotherapy for youth with SMD (IPT-SMD)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Retention rate [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    We are assessing the feasibility and acceptability of IPT-SMD in anticipation of conducting a larger trial.


Secondary Outcome Measures:
  • Clinical Global Impressions Scale CGI-I (SMD) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    We will utilize the CGI-I (SMD) to assess the effectiveness of IPT-SMD on the severity of SMD symptoms in youth with SMD.


Estimated Enrollment: 5
Study Start Date: July 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
therapy
All participants will receive the intervention.
Behavioral: Interpersonal Psychotherapy for youth with SMD (IPT-SMD)
Youth will receive weekly therapy sessions for 16 weeks and then bi-weekly session until week 20. Parent sessions will also be included.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591564

Contacts
Contact: Leslie Miller, M.D. 410-550-9014

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Leslie Miller, M.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Leslie Miller, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Leslie Miller, M.D., Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01591564     History of Changes
Other Study ID Numbers: NA_00046454, K23MH090246
Study First Received: May 2, 2012
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
interpersonal psychotherapy
severe mood dysregulation

ClinicalTrials.gov processed this record on April 17, 2014