Trial Outcomes & Findings for Comparison of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Depression (NCT NCT01740726)

Results Overview

Self-report measure, completed by the child, that assesses depressive symptom severity. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. Change is the difference between the 42 week score and the baseline score.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

Baseline, 42 weeks

Results posted on

2017-12-20

Participant Flow

Two subjects were screen failures and were not randomized into either arm of the study.

Participant milestones

Participant milestones
Measure	Behavioral Activation Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.	Fluoxetine Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Activation Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.	Fluoxetine n=1 Participants Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 42 weeks

Self-report measure, completed by the child, that assesses depressive symptom severity. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. Change is the difference between the 42 week score and the baseline score.