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

This study is currently recruiting participants.
Verified April 2013 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01447602
First received: September 28, 2011
Last updated: April 26, 2013
Last verified: April 2013

September 28, 2011
April 26, 2013
September 2011
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01447602 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Clinical Trial of IPT-A to Prevent Suicide in Depressed Adolescents With Suicidal Behavior
An Open Clinical Trial of IPT-A to Prevent Suicide in Depressed Adolescents With Suicidal Behavior

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Unipolar Depression
  • Dysthymia
Behavioral: IPT-A
Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy as an intervention for adolescent depression
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.
Intervention: Behavioral: IPT-A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
12 Months to 19 Years
No
Contact: Laura Mufson, PhD 212-543-5561 MufsonL@nyspi.columbia.edu
Contact: Moira Rynn, MD 212-543-4506 RynnM@nyspi.columbia.edu
United States
 
NCT01447602
6238
No
New York State Psychiatric Institute
New York State Psychiatric Institute
Not Provided
Principal Investigator: Laura Mufson, PhD New York State Psychiatric Institute
New York State Psychiatric Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP