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

Primary Purpose

Unipolar Depression, Dysthymia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IPT-A
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unipolar Depression focused on measuring Major Depressive Disorder (MDD), Dysthymia, Depressive Disorder Not Otherwise Specified (DDNOS)

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Presbyterian Hospital
  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interpersonal psychotherapy (IPT-A)

Arm Description

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.

Outcomes

Primary Outcome Measures

Score on Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a scale that assesses for the presence of suicidal behavior.

Secondary Outcome Measures

Change in score on Children's Depression Rating Scale (CDRS)
The CDRS is a clinician rated instrument that assesses for the presence and severity of depressive symptoms.

Full Information

First Posted
September 28, 2011
Last Updated
September 2, 2014
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01447602
Brief Title
A Clinical Trial of IPT-A to Prevent Suicide in Depressed Adolescents With Suicidal Behavior
Acronym
IPT-A-CSP
Official Title
An Open Clinical Trial of IPT-A to Prevent Suicide in Depressed Adolescents With Suicidal Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression, Dysthymia
Keywords
Major Depressive Disorder (MDD), Dysthymia, Depressive Disorder Not Otherwise Specified (DDNOS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal psychotherapy (IPT-A)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
IPT-A
Intervention Description
Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy as an intervention for adolescent depression
Primary Outcome Measure Information:
Title
Score on Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is a scale that assesses for the presence of suicidal behavior.
Time Frame
Up to 42 weeks
Secondary Outcome Measure Information:
Title
Change in score on Children's Depression Rating Scale (CDRS)
Description
The CDRS is a clinician rated instrument that assesses for the presence and severity of depressive symptoms.
Time Frame
Week 20 and 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Mufson, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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

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