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

Primary Purpose

Adolescent Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
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 - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adolescents and parents must be English-speaking
  • Completed acute phase treatment (NCT01802437) and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I < 3)).

Exclusion Criteria:

- Did not completed acute phase treatment (NCT01802437) or did not show at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I < 3)) to acute phase treatment.

Sites / Locations

  • University of Minnesota, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

6 IPT-A Sessions

6 IPT-A Sessions + Continue Current Dose of Fluoxetine

10 IPT-A Sessions + Begin Fluoxetine

10 IPT-A Sessions + Increase Dose of Fluoxetine

Arm Description

Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) only. During the Continuation IPT-A sessions, the therapist will continue to emphasize the interpersonal strategies that were learned and practiced during the acute phase, and address any current interpersonal problems before they result in a recurrence of depressive symptoms. Adolescents who have responded to acute phase treatment (CGI-I = much improved or very much improved) will attend 4 biweekly IPT-A sessions followed by 2 monthly sessions.

Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment. Adolescents who have responded to acute phase treatment (CGI-I = much improved or very much improved) will attend 4 biweekly IPT-A sessions followed by 2 monthly sessions and will continue their acute phase fluoxetine dosing regimen and will meet with the psychiatrist on a monthly basis.

Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment. Adolescents who received only IPT-A during acute phase and who showed a partial response (CGI-I = minimally improved) will attend 8 weekly IPT-A sessions followed by 2 monthly sessions and will begin treatment with fluoxetine during the continuation phase.The dosage schedule will be 10mg per day for the first week and 20mg per day for the following 5 weeks. If no treatment response is observed by the 6th week, the dosage can be increased to 40mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and biweekly thereafter. Pharmacotherapy sessions will include assessment of vital signs, adverse effects, safety, and symptomatic response.

Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment. Adolescents who received IPT-A and fluoxetine during the acute phase and were partial responders (CGI-I = minimally improved) will attend 8 weekly IPT-A sessions followed by 2 monthly sessions and will have their fluoxetine dose increased to 60mg. Partial responders will meet with the psychiatrist biweekly for the first 2 months and monthly for the second 2 months.

Outcomes

Primary Outcome Measures

Children's Depression Rating Scale-Revised (CDRS-R)
The CDRS-R is a clinician-administered semi-structured interview designed to assess present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria. This survey contains 17 items; 3 items are rated on a scale from 0 to 5, 5 items are rated on a scale from 0 to 6, and the remaining 9 items are rated on a scale from 0 to 7. Total score is a raw sum of the 17 item scores and ranges from 0 to 108. Higher scores indicate greater depression severity.
Children's Global Assessment Scale (CGAS)
The CGAS is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. Scores range from 1 to 100, with higher scores indicating better functioning.
Beck Depression Inventory-II (BDI-II)
BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms reflective of DSM-IV diagnostic criteria over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms.
Social Adjustment Scale - Self Report (SAS-SR)
The SAS-SR is a 42-item self report measure of role performance in the past 2 weeks. Items are rated on a 5-point scale. Total scores are calculated by summing the 42 item scores and dividing by the total number of items answered. Total scores range from 1 to 5, with higher scores indicating greater impairment of functioning.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2013
Last Updated
March 9, 2020
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02017535
Brief Title
An Adaptive Treatment Strategy for Adolescent Depression-Continuation
Acronym
PTAD GIA
Official Title
A Personalized Approach to Achieving a Sustained Response to Treatment for Adolescent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (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
Aim 1: Assess the feasibility and acceptability of the personalized continuation treatment strategy. Aim 2: Estimate variances of primary and secondary outcomes with the continuation treatment. Aim 3: Conduct exploratory hypothesis-generating analyses to inform further development of the personalized continuation treatment strategy to be tested in a subsequent R01 proposal.
Detailed Description
Male and female adolescents (ages 12-18) will be eligible for the study if they completed acute phase treatment and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I < 3)). Adolescents will enter continuation treatment having either received 12 sessions of IPT-A, 16 sessions of IPT-A, or 12 sessions of IPT-A plus fluoxetine.This is a continuation of the study "An Adaptive Treatment Strategy for Adolescent Depression (PTAD)" NCT01802437

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
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6 IPT-A Sessions
Arm Type
Active Comparator
Arm Description
Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) only. During the Continuation IPT-A sessions, the therapist will continue to emphasize the interpersonal strategies that were learned and practiced during the acute phase, and address any current interpersonal problems before they result in a recurrence of depressive symptoms. Adolescents who have responded to acute phase treatment (CGI-I = much improved or very much improved) will attend 4 biweekly IPT-A sessions followed by 2 monthly sessions.
Arm Title
6 IPT-A Sessions + Continue Current Dose of Fluoxetine
Arm Type
Active Comparator
Arm Description
Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment. Adolescents who have responded to acute phase treatment (CGI-I = much improved or very much improved) will attend 4 biweekly IPT-A sessions followed by 2 monthly sessions and will continue their acute phase fluoxetine dosing regimen and will meet with the psychiatrist on a monthly basis.
Arm Title
10 IPT-A Sessions + Begin Fluoxetine
Arm Type
Experimental
Arm Description
Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment. Adolescents who received only IPT-A during acute phase and who showed a partial response (CGI-I = minimally improved) will attend 8 weekly IPT-A sessions followed by 2 monthly sessions and will begin treatment with fluoxetine during the continuation phase.The dosage schedule will be 10mg per day for the first week and 20mg per day for the following 5 weeks. If no treatment response is observed by the 6th week, the dosage can be increased to 40mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and biweekly thereafter. Pharmacotherapy sessions will include assessment of vital signs, adverse effects, safety, and symptomatic response.
Arm Title
10 IPT-A Sessions + Increase Dose of Fluoxetine
Arm Type
Experimental
Arm Description
Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment. Adolescents who received IPT-A and fluoxetine during the acute phase and were partial responders (CGI-I = minimally improved) will attend 8 weekly IPT-A sessions followed by 2 monthly sessions and will have their fluoxetine dose increased to 60mg. Partial responders will meet with the psychiatrist biweekly for the first 2 months and monthly for the second 2 months.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Other Intervention Name(s)
IPT
Intervention Description
Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Primary Outcome Measure Information:
Title
Children's Depression Rating Scale-Revised (CDRS-R)
Description
The CDRS-R is a clinician-administered semi-structured interview designed to assess present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria. This survey contains 17 items; 3 items are rated on a scale from 0 to 5, 5 items are rated on a scale from 0 to 6, and the remaining 9 items are rated on a scale from 0 to 7. Total score is a raw sum of the 17 item scores and ranges from 0 to 108. Higher scores indicate greater depression severity.
Time Frame
16 weeks, 32 weeks
Title
Children's Global Assessment Scale (CGAS)
Description
The CGAS is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. Scores range from 1 to 100, with higher scores indicating better functioning.
Time Frame
16 weeks, 32 weeks
Title
Beck Depression Inventory-II (BDI-II)
Description
BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms reflective of DSM-IV diagnostic criteria over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms.
Time Frame
16 weeks, 32 weeks
Title
Social Adjustment Scale - Self Report (SAS-SR)
Description
The SAS-SR is a 42-item self report measure of role performance in the past 2 weeks. Items are rated on a 5-point scale. Total scores are calculated by summing the 42 item scores and dividing by the total number of items answered. Total scores range from 1 to 5, with higher scores indicating greater impairment of functioning.
Time Frame
16 weeks, 32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescents and parents must be English-speaking Completed acute phase treatment (NCT01802437) and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I < 3)). Exclusion Criteria: - Did not completed acute phase treatment (NCT01802437) or did not show at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I < 3)) to acute phase treatment.
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

Citations:
PubMed Identifier
30577943
Citation
Gunlicks-Stoessel M, Mufson L, Bernstein G, Westervelt A, Reigstad K, Klimes-Dougan B, Cullen K, Murray A, Vock D. Critical Decision Points for Augmenting Interpersonal Psychotherapy for Depressed Adolescents: A Pilot Sequential Multiple Assignment Randomized Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):80-91. doi: 10.1016/j.jaac.2018.06.032. Epub 2018 Oct 27.
Results Reference
derived

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An Adaptive Treatment Strategy for Adolescent Depression-Continuation

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