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Completed

NCT Number: NCT01591564

Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

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.

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Key information

Conditions

Severe Mood Dysregulation

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interpersonal Psychotherapy for youth with SMD (IPT-SMD)

Behavioral

Youth will receive weekly therapy sessions for 16 weeks and then bi-weekly session until week 20. Parent sessions will also be included.

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 4, 2012
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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