Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014