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

NCT ID: NCT01447602

Last Updated: 2014-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-06-30

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.

Conditions

Unipolar Depression; Dysthymia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IPT-A

Intervention Type: BEHAVIORAL

Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy as an intervention for adolescent depression

Interventions

IPT-A

Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy as an intervention for adolescent depression

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Mufson, PhD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York Presbyterian Hospital

New York, New York, United States

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

6238

Identifier Type: -

Identifier Source: org_study_id