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

NCT01447602 | Completed Phase 3

• 1 other identifier: 6238
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Unipolar Depression; Dysthymia

Keywords

Major Depressive Disorder (MDD); Dysthymia; Depressive Disorder Not Otherwise Specified (DDNOS)

Outcome Measures

Primary Outcomes (1)

• Score on Columbia Suicide Severity Rating Scale (C-SSRS)

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

  Up to 42 weeks

Secondary Outcomes (1)

• Change in score on Children's Depression Rating Scale (CDRS)

  Week 20 and 3 month follow-up

Study Arms (1)

Interpersonal psychotherapy (IPT-A)

EXPERIMENTAL

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

Interventions

IPT-A BEHAVIORAL

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

Interpersonal psychotherapy (IPT-A)

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (2)

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Dysthymic Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Laura Mufson, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: October 6, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 4, 2014

Record last verified: 2013-04

Locations

US (2)