An Adaptive Treatment Strategy for Adolescent Depression-Continuation

NCT02017535 | Completed Phase 1 Results DMC

• 1 other identifier: 1206M15365
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Depression

Outcome Measures

Primary Outcomes (4)

• 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.

  16 weeks, 32 weeks

• 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.

  16 weeks, 32 weeks

• 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.

  16 weeks, 32 weeks

• 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.

  16 weeks, 32 weeks

Study Arms (4)

6 IPT-A Sessions

ACTIVE COMPARATOR

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.

Behavioral: Interpersonal Psychotherapy

6 IPT-A Sessions + Continue Current Dose of Fluoxetine

ACTIVE COMPARATOR

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.

Drug: Fluoxetine; Behavioral: Interpersonal Psychotherapy

10 IPT-A Sessions + Begin Fluoxetine

EXPERIMENTAL

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.

Drug: Fluoxetine; Behavioral: Interpersonal Psychotherapy

10 IPT-A Sessions + Increase Dose of Fluoxetine

EXPERIMENTAL

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.

Drug: Fluoxetine; Behavioral: Interpersonal Psychotherapy

Interventions

Fluoxetine DRUG

Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.

Also known as: Prozac

10 IPT-A Sessions + Begin Fluoxetine; 10 IPT-A Sessions + Increase Dose of Fluoxetine; 6 IPT-A Sessions + Continue Current Dose of Fluoxetine

Interpersonal Psychotherapy BEHAVIORAL

Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.

Also known as: IPT

10 IPT-A Sessions + Begin Fluoxetine; 10 IPT-A Sessions + Increase Dose of Fluoxetine; 6 IPT-A Sessions; 6 IPT-A Sessions + Continue Current Dose of Fluoxetine

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)).

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota, Department of Psychiatry

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• 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.

  PMID: 30577943 DERIVED

MeSH Terms

Interventions

Fluoxetine; Interpersonal Psychotherapy

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Meredith Gunlicks-Stoessel
• Organization: University of Minnesota

mgunlick@umn.edu

612-273-9844

Study Officials

• Meredith Gunlicks-Stoessel, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: June 1, 2012
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 23, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Locations

US (1)