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Adolescent Depression | An Adaptive Treatment Strategy for Adolescent Depression

Adolescent Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Adolescent Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:FluoxetineIf 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.

Behavioral:Increased Dose of Interpersonal PsychotherapyIf 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.

Behavioral:Continue to Receive Initial Dose of Interpersonal PsychotherapyIf 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Talk Therapy 4-Week Decision PointInterpersonal 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

Talk Therapy 8-Week Decision PointInterpersonal 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.

Study Status

Completed

Start Date: November 2010

Completed Date: June 2016

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: CDRS-R Score

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Meredith Gunlicks-Stoessel, PhD

Lead Sponsor: University of Minnesota - Clinical and Translational Science Institute

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01802437

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