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An Adaptive Treatment Strategy for Adolescent Depression (PTAD)

Primary Purpose

Adolescent Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Increased Dose of Interpersonal Psychotherapy
Continue to Receive Initial Dose of Interpersonal Psychotherapy
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adolescent Depression

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 intellectual disability disorder.
  • 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.

Sites / Locations

  • University of Minnesota, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Talk Therapy 4-Week Decision Point

Talk Therapy 8-Week Decision Point

Arm Description

Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy

Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.

Outcomes

Primary Outcome Measures

CDRS-R Score
The CDRS-R is a clinician-administered semi-structured interview that assesses symptoms of depression experienced during the previous 2-weeks. The first 14 items are rated on the basis of an interview. The remaining 3 items are rated by a clinician on the basis of the child's nonverbal behavior. Items scales are 1 to 5 for sleep, appetite, and speech and 1 to 7 for the remaining 14 items. Total scores are summed and range from 17 to 113, with lower scores indicating normality while higher scores indicate psychopathology. Lower scores post-intervention indicate treatment efficacy.
CGAS Score
The Children's Global Assessment Scale (CGAS) is a numeric scale used by mental health clinicians to rate the general functioning. Scores range from 1 to 100, with high scores indicating better functioning. A score of 1-10 indicates the need for constant supervision, while a score of 91-100 indicates superior functioning.
SAS-SR Score
The SAS-SR provides an understanding of an individual's level of satisfaction with his or her social situation, measuring the level of both behavioral and emotional social adjustment across four major areas (school, friends, family, and dating). Participants answer each item on a scale of 1 to 5. The total score also ranges from 1 to 5 and is the average of all item scores. The total score provides an index of social impairment with higher mean score indicating more difficulties with social adjustment. Lower scores post treatment indicate efficacy of the intervention.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2013
Last Updated
July 10, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01802437
Brief Title
An Adaptive Treatment Strategy for Adolescent Depression
Acronym
PTAD
Official Title
An Adaptive Treatment Strategy for Adolescent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is: 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 to compare two ways of providing treatment to teenagers who have not improved enough.
Detailed Description
Study Procedures This study has three phases: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Talk Therapy 4-Week Decision Point
Arm Type
Experimental
Arm Description
Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy
Arm Title
Talk Therapy 8-Week Decision Point
Arm Type
Experimental
Arm Description
Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increase in therapy (4 extra therapy sessions) or fluoxetine therapy. 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. If no treatment response was observed by the sixth week, the dosage could be increased to 40 mg per day.
Intervention Type
Behavioral
Intervention Name(s)
Increased Dose of Interpersonal Psychotherapy
Intervention Description
If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increased dose of interpersonal psychotherapy (4 extra therapy sessions) or fluoxetine.
Intervention Type
Behavioral
Intervention Name(s)
Continue to Receive Initial Dose of Interpersonal Psychotherapy
Intervention Description
If Hamilton Rating Scale for Depression scores meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be assigned to continue initial dose of interpersonal psychotherapy.
Primary Outcome Measure Information:
Title
CDRS-R Score
Description
The CDRS-R is a clinician-administered semi-structured interview that assesses symptoms of depression experienced during the previous 2-weeks. The first 14 items are rated on the basis of an interview. The remaining 3 items are rated by a clinician on the basis of the child's nonverbal behavior. Items scales are 1 to 5 for sleep, appetite, and speech and 1 to 7 for the remaining 14 items. Total scores are summed and range from 17 to 113, with lower scores indicating normality while higher scores indicate psychopathology. Lower scores post-intervention indicate treatment efficacy.
Time Frame
Baseline and 16-weeks
Title
CGAS Score
Description
The Children's Global Assessment Scale (CGAS) is a numeric scale used by mental health clinicians to rate the general functioning. Scores range from 1 to 100, with high scores indicating better functioning. A score of 1-10 indicates the need for constant supervision, while a score of 91-100 indicates superior functioning.
Time Frame
Baseline and 16-weeks
Title
SAS-SR Score
Description
The SAS-SR provides an understanding of an individual's level of satisfaction with his or her social situation, measuring the level of both behavioral and emotional social adjustment across four major areas (school, friends, family, and dating). Participants answer each item on a scale of 1 to 5. The total score also ranges from 1 to 5 and is the average of all item scores. The total score provides an index of social impairment with higher mean score indicating more difficulties with social adjustment. Lower scores post treatment indicate efficacy of the intervention.
Time Frame
Baseline and 16-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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 intellectual disability disorder. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meredith Gunlicks-Stoessel, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota, Department of Psychiatry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

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An Adaptive Treatment Strategy for Adolescent Depression

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