An Adaptive Treatment Strategy for Adolescent Depression (PTAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01802437
First received: February 1, 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: An Adaptive Treatment Strategy 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 4/8/12/16/32 [ 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 4/8/12/16/32 [ 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 4/8/12/16/32 [ 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: November 2010
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)
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)

Detailed Description:

Study Procedures

This study has three phases:

  1. The screening and eligibility phase:

    Parent and child will conduct an initial evaluation that will last about 4 hours. The evaluator will ask questions and the participant will complete forms about his/her mood and behavior. This intake appointment will determine eligibility for the study.

  2. The treatment phase: The child would begin a kind of talk therapy called interpersonal psychotherapy. The goal of the therapy is to decrease teenagers' depression by helping them improve their relationships and communication skills. The child will attend 12 therapy appointments over the course of 16 weeks. Each appointment will be 50 minutes long.

    If the child is doing well with standard interpersonal therapy, it will be continued without change. If the child has not improved enough, we will change the treatment plan in one of two ways. The choice will be based on chance (sort of like flipping a coin) and will be done by a computer.

    ***Your child will attend 16 therapy appointments (that is four additional sessions). These additional four sessions will be scheduled so that your child will attend therapy twice a week for a period of four weeks.

    -OR-

    ***Your child will continue to attend 12 therapy appointments over the course of 16 weeks and your child will also be prescribed an antidepressant medication called fluoxetine. Fluoxetine is also known as Prozac. Prozac has been approved by the Food and Drug Administration for use in the treatment of depressed teenagers. You will be responsible for paying for the medication.

    At four points during the treatment phase (week 4, week 8, week 12, and week 16), parent and child will be asked to complete forms and interviews to see how the child is doing. The evaluations at weeks 4, 8, and 12 will take approximately 1 hour. At the end of treatment, parent and child will have a longer meeting with the evaluator (4 hours) to see if the treatment your child got was helpful. During these meetings, we will also ask participants to fill out some forms about your mood and mental health treatment.

  3. The follow-up phase: Parent and child will be asked to return for a follow-up assessment 4 months after the child completes the treatment phase to see how he or she is doing. Parent and child will be asked to complete forms and interviews. This meeting will take approximately 4 hours.
  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: NCT01802437

Contacts
Contact: Ana Bortnova, 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
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: NCT01802437     History of Changes
Other Study ID Numbers: 1110M05542
Study First Received: February 1, 2013
Last Updated: January 10, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
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 August 28, 2014