Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT01447602
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2011-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial of IPT-A to Prevent Suicide in Depressed Adolescents With Suicidal Behavior
Sponsor:
New York State Psychiatric Institute
Organization:
Study Overview
Official Title:
An Open Clinical Trial of IPT-A to Prevent Suicide in Depressed Adolescents With Suicidal Behavior
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPT-A-CSP
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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: