University of Minnesota, Department of Psychiatry
Minneapolis, Minnesota, 55454, United States
NCT Number: NCT01802437
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.
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Notify Me12 year–17 year
All sexes
Interventional
Phase 1 / Phase 2
Minneapolis, Minnesota, 55454, United States
Study Procedures
This study has three phases:
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Prozac
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.
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.
Time frame: Baseline and 16-weeks
The CDRS-R is a clinician-administered semi-structured interview that assesses symptoms of depression experienced during the previous 2-weeks. The first 14 items are rated on the basis of an interview. The remaining 3 items are rated by a clinician on the basis of the child's nonverbal behavior. Items scales are 1 to 5 for sleep, appetite, and speech and 1 to 7 for the remaining 14 items. Total scores are summed and range from 17 to 113, with lower scores indicating normality while higher scores indicate psychopathology. Lower scores post-intervention indicate treatment efficacy.
Time frame: Baseline and 16-weeks
The Children's Global Assessment Scale (CGAS) is a numeric scale used by mental health clinicians to rate the general functioning. Scores range from 1 to 100, with high scores indicating better functioning. A score of 1-10 indicates the need for constant supervision, while a score of 91-100 indicates superior functioning.
Time frame: Baseline and 16-weeks
The SAS-SR provides an understanding of an individual's level of satisfaction with his or her social situation, measuring the level of both behavioral and emotional social adjustment across four major areas (school, friends, family, and dating). Participants answer each item on a scale of 1 to 5. The total score also ranges from 1 to 5 and is the average of all item scores. The total score provides an index of social impairment with higher mean score indicating more difficulties with social adjustment. Lower scores post treatment indicate efficacy of the intervention.
University of Minnesota
Other
Acronym: PTAD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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