Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Leslie Miller, M.D., Johns Hopkins University Identifier:
First received: May 2, 2012
Last updated: March 30, 2015
Last verified: March 2015

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 Leslie Miller, M.D., Johns Hopkins University:

Primary Outcome Measures:
  • Retention rate [ Time Frame: 20 weeks ]
    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 ]
    We will utilize the CGI-I (SMD) to assess the effectiveness of IPT-SMD on the severity of SMD symptoms in youth with SMD.

Enrollment: 3
Study Start Date: July 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   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
  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 identifier: NCT01591564

United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute of Mental Health (NIMH)
Principal Investigator: Leslie Miller, M.D. Johns Hopkins University
  More Information

Responsible Party: Leslie Miller, M.D., Assistant Professor, Johns Hopkins University Identifier: NCT01591564     History of Changes
Other Study ID Numbers: NA_00046454
K23MH090246 ( US NIH Grant/Contract Award Number )
Study First Received: May 2, 2012
Last Updated: March 30, 2015

Keywords provided by Leslie Miller, M.D., Johns Hopkins University:
interpersonal psychotherapy
severe mood dysregulation processed this record on May 25, 2017