NCT01802437

An Adaptive Treatment Strategy for Adolescent Depression

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Procedures This study has three phases: 1. 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. 2. 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. 3. 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.

Conditions

• Adolescent Depression

Interventions

Type	Name	Description
DRUG	Fluoxetine	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.
BEHAVIORAL	Increased Dose of Interpersonal Psychotherapy	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.
BEHAVIORAL	Continue to Receive Initial Dose of Interpersonal Psychotherapy	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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-03-01
• Last updated: 2019-07-11
• Results posted: 2019-07-11

Locations

1 site across 1 country: United States