An Adaptive Treatment Strategy for Adolescent Depression-Continuation (PTAD GIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
University of Minnesota - Grant-in-Aid of Research, Artistry, & Scholarship
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02017535
First received: December 16, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The purpose of the study is:

  1. To find out how long teenagers getting talk therapy (interpersonal psychotherapy) for depression should get therapy before the therapist decides whether or not the teenager is improving enough, and
  2. To compare two ways of providing treatment to teenagers who have not improved enough.

Condition Intervention Phase
Adolescent Depression
Drug: Fluoxetine
Behavioral: Interpersonal Psychotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Personalized Approach to Achieving a Sustained Response to Treatment for Adolescent Depression

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • K-SADS-PL - baseline; change from baseline in KSADS at week 16 and 32 [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Clinician-administered semi-structured interview designed to assess present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria.

  • BDI-II-baseline; change from baseline in BDI at weeks 4/8/12/16/24/32 [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    A self-report measure that assesses the severity of 21 depressive symptoms reflective of DSM-IV diagnostic criteria over the prior week.

  • HRSD-baseline; change from baseline in HRSD at weeks 4/8/12/16/24/32 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A clinician-administered semi-structured interview measure developed to assess the severity of depression symptoms. It was initially designed for use with adults, but is widely used with adolescents, as well. It will also be used by the study clinicians in the first and fourth therapy sessions to guide implementation of the adaptive treatment strategy.

  • CSSR-S-baseline; change from baseline in CSSR-S at weeks 4/8/12/16/24/32 [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    A clinician-administered standardized suicidal rating system that is based on definitions of suicidality derived from empirical findings on the phenomenology of suicidality and identified predictive and risk factors.


Estimated Enrollment: 45
Study Start Date: June 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interpersonal Psychotherapy
Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Behavioral: Interpersonal Psychotherapy
Adolescent randomized to an increase in therapy (4 extra therapy sessions)
Other Name: IPT
Fluoxetine
The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. The medication will be taken as a daily pill.
Drug: Fluoxetine
Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.
Other Name: Prozac
Behavioral: Interpersonal Psychotherapy
Adolescent randomized to an increase in therapy (4 extra therapy sessions)
Other Name: IPT

Detailed Description:

This is a continuation of the study "An Adaptive Treatment Strategy for Adolescent Depression (PTAD) "

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescent meets DSM-IV-TR criteria for a diagnosis of Major Depressive Disorder, Dysthymia, or Depressive Disorder NOS; demonstrate symptoms of depression (CDRS-R > 35); and demonstrate impairment in general functioning (CGAS < 65).
  • Adolescents and parents must be English-speaking

Exclusion Criteria:

  • Adolescent meets criteria for a diagnosis of Schizophrenia, Bipolar Disorder, Psychosis, Substance Abuse, OCD, Conduct Disorder, Eating Disorder, PDD, or Mental Retardation.
  • Depressed adolescents who are actively suicidal with a plan and/or intent
  • Adolescent that are already receiving treatment for depression or if they are taking medication for a psychiatric diagnosis other than ADHD. Depressed adolescents with a comorbid diagnosis of ADHD who are on a stable dose of stimulant medication (> 3 months) will be eligible to participate in the studies.
  • Adolescent that have already received an adequate trial of IPT-A or fluoxetine.
  • Female adolescents who are pregnant, breastfeeding, or having unprotected sexual intercourse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017535

Contacts
Contact: Ana Westervelt, BA 6126267065 bortn005@umn.edu
Contact: Alaa Houri, BS 6126267886 houri005@umn.edu

Locations
United States, Minnesota
University of Minnesota, Department of Psychiatry Recruiting
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Grant-in-Aid of Research, Artistry, & Scholarship
Investigators
Principal Investigator: Meredith Gunlicks-Stoessel, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02017535     History of Changes
Other Study ID Numbers: 1206M15365
Study First Received: December 16, 2013
Last Updated: January 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014