CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Fluoxetine +2 moredrug
Likely dose
Fluoxetine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01802437
NCT01802437Phase 2Completed
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An Adaptive Treatment Strategy for Adolescent Depression

University of Minnesota·interventional·Posted Mar 1, 2013·Updated Jul 11, 2019

In Brief

A Phase 2 clinical trial evaluating Fluoxetine, Increased Dose of Interpersonal Psychotherapy, and 1 other intervention for Adolescent Depression. Completed, enrolled 40 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdolescent Depression
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2013
Enrollment StartNov 1, 2010
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 13.3 years ago

Interventions

Fluoxetinedrug

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.

Increased Dose of Interpersonal Psychotherapybehavioral

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.

Continue to Receive Initial Dose of Interpersonal Psychotherapybehavioral

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.