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A Clinical Trial of IPT-A to Prevent Suicide in Depressed Adolescents With Suicidal Behavior (IPT-A-CSP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01447602
First received: September 28, 2011
Last updated: September 2, 2014
Last verified: April 2013
History of Changes
  Purpose

The investigators are adapting Interpersonal Psychotherapy (IPT-A) for adolescents who are referred to emergency services either for a suicide attempt or for being evaluated as high risk for suicidal behavior. The investigators will recruit 15 adolescents ages 12-19 years who present with a diagnosis of major depression, dysthymic disorder, depression disorder not otherwise specified who have a history of a suicide attempt in the past 2 months or a non-medically lethal attempt that may require psychiatric hospitalization, suicide attempt that is or report current suicidal ideation with a plan/intent, and treat them in an open clinical trial. The treatment will be conducted twice weekly for the first 8 weeks of treatment and then weekly for the remaining 12 weeks of the study. Using feedback from clinicians and participants, the investigators will make further modifications to the manual in preparation for conducting a larger controlled clinical trial.


Condition Intervention Phase
Unipolar Depression
Dysthymia
 Behavioral: IPT-A
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Clinical Trial of IPT-A to Prevent Suicide in Depressed Adolescents With Suicidal Behavior

Resource links provided by NLM:

MedlinePlus related topics: Suicide
U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Score on Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 42 weeks ] [ Designated as safety issue: Yes ]
    The C-SSRS is a scale that assesses for the presence of suicidal behavior.


Secondary Outcome Measures:
  • Change in score on Children's Depression Rating Scale (CDRS) [ Time Frame: Week 20 and 3 month follow-up ] [ Designated as safety issue: Yes ]
    The CDRS is a clinician rated instrument that assesses for the presence and severity of depressive symptoms.
Enrollment: 10
Study Start Date: September 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interpersonal psychotherapy (IPT-A)
Interpersonal psychotherapy for depressed adolescents which focuses on identifying problematic relationships connected to onset or maintenance of depression and suicidal behavior. The treatment teaches skills such as communication and problem-solving to the adolescent and parents.
 Behavioral: IPT-A
Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy as an intervention for adolescent depression

Detailed Description:

All treatment will be done on the Children's Day Unit (CDU) and the adolescent and his/her family need to agree to participate in the CDU program. The acute phase is biweekly for 8 weeks followed by weekly sessions for the remaining 12 weeks to allow for continued work on the skills and for consolidation of skills to prevent relapse. It is a total of 28 sessions in 20 weeks. There also are up to 4 additional emergency sessions that can be used to handle crises or have additional parent sessions during those 20 weeks. In addition, the child and adolescent psychiatrist will evaluate each study participant in terms of presently prescribed medication or for the need to initiate pharmacological treatment which will follow the evidence based medicine recommendations for pediatric psychopharmacology (Walkup et al., 2009). The child and adolescent psychiatrist will see each study participant weekly for monitoring of illness severity and medication management. Over the course of the 20 week treatment, the investigators will assess their diagnosis, global functioning, severity of depression, anxiety and suicidal ideation, and family factors. At each therapy session, the adolescents will be assessed for suicidal behavior by their clinician. They also will be seen every 4 weeks by an independent evaluator who will track their symptoms and functioning at weeks 4, 8, 12, 16, 20 or early termination and week 32 follow-up assessments. The open trial will allow us to determine the feasibility of recruiting depressed and suicidal youth. It also will allow us to determine the benefits of using IPT-A to treat depressed and suicidal youth.

  Eligibility
Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females ages 12-19 years
  • English speaking adolescent
  • Parent may be monolingual or bilingual in Spanish
  • DSM-IV diagnosis of MDD, dysthymia, DDNOS
  • Moderate impairment in functioning
  • Moderate to severe depression severity
  • Expressed risk for suicide or reported non-medically lethal attempt. Non-lethal attempt is defined as an attempt that did not require medical hospitalization but may require psychiatric hospitalization which often includes being in the Emergency Room for several days because there was no bed available.

Exclusion Criteria:

  • Suicide attempt in the past 4 months with medical lethality that requires hospitalization which often includes being in the ER for several days because there was no bed available.
  • Severe impairment in functioning
  • Diagnoses of Substance abuse, Schizophrenia, bipolar disorder,Conduct disorder, primary eating disorder, Psychosis, obsessive-compulsive disorder,
  • Engagement in self-injurious that requires medical treatment in the past month
  • Mental retardation or severe learning disability
  • Medical illness that may interfere with treatment
  • Current physical or sexual abuse
  • Open Administration for Children's Services (ACS) case
  • Pregnancy
  • Already receiving treatment for depression or have begun a medication trial for another diagnosis within the previous three months
  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: NCT01447602

Locations
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10032
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Laura Mufson, PhD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01447602     History of Changes
Other Study ID Numbers: 6238
Study First Received: September 28, 2011
Last Updated: September 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Major Depressive Disorder (MDD)
Dysthymia
Depressive Disorder Not Otherwise Specified (DDNOS)

ClinicalTrials.gov processed this record on February 27, 2015