Clinical Trial: A Clinical Trial of IPT-A to Prevent Suicide in Depressed Adolescents With Suicidal Behavior

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Clinical Trial of IPT-A to Prevent Suicide in Depressed Adolescents With Suicidal Behavior

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: New York State Psychiatric Institute

Current Primary Outcome: Score on Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 42 weeks ]

The C-SSRS is a scale that assesses for the presence of suicidal behavior.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in score on Children's Depression Rating Scale (CDRS) [ Time Frame: Week 20 and 3 month follow-up ]

The CDRS is a clinician rated instrument that assesses for the presence and severity of depressive symptoms.


Original Secondary Outcome: Same as current

Information By: New York State Psychiatric Institute

Dates:
Date Received: September 28, 2011
Date Started: September 2011
Date Completion:
Last Updated: September 2, 2014
Last Verified: April 2013