Comparison of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Depression
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|ClinicalTrials.gov Identifier: NCT01740726|
Recruitment Status : Terminated (Lack of success with recruitment)
First Posted : December 4, 2012
Results First Posted : April 7, 2015
Last Update Posted : December 20, 2017
This study focuses on treating adolescents with depression. The study has two main purposes. The first is to compare a new form of therapy for depression called Behavioral Activation (BA) to the antidepressant medication fluoxetine. BA therapy helps depressed people get more involved in activities they find enjoyable, which can reduce symptoms of depression. Research shows that both BA and fluoxetine work to reduce depressive symptoms in adolescents. However, unlike previous research, this study examines how well the two treatment options work in comparison to each other. Participants in the study are randomized to receive treatment with either BA or fluoxetine for 18 weeks.
The second aim of the study is to examine the brain functions of adolescents in both treatment groups. Participants undergo functional Magnetic Resonance Imaging (fMRI) scans before and after treatment. The data from these scans will be used to compare the brains of participants in the BA condition with those in the fluoxetine condition. Also, the scans may show possible differences between participants' brains before and after treatment. These data may help scientists determine the ideal form of depression treatment for different types of people.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: Behavioral Activation Drug: Fluoxetine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Trial of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Major Depression|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
|Experimental: Behavioral Activation||
Behavioral: 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.
|Active Comparator: 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.
- Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II) [ Time Frame: 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.
- Change in Depressive Symptoms From Baseline Based on Children's Depression Rating Scale - Revised (CDRS-R) [ Time Frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks. ]Interview-based measure, completed with both the parent and child, that assesses depression severity.
- Overall Improvement and Change in Symptom Severity From Baseline Based on Clinical Global Impression - Improvement and Severity (CGI-I, CGI-S) [ Time Frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks. ]Clinician's rating of symptom severity and improvement since baseline.
- Change in Behaviors From Baseline Based on Behavioral Activation for Depression Scale (BADS) [ Time Frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks. ]Assesses behavioral changes on 4 subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.
- Change in Anxiety From Baseline Based on Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks. ]Measures anxiety symptom severity.
- Change in Suicidal Ideation Based on Suicidal Ideation Questionnaire (SIQ) [ Time Frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks. ]Assesses seriousness of suicidal intent.
- Change in Hope Based on Children's Hope Scale (CHS) [ Time Frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks. ]Assesses self-perception of ability to set and work toward goals.
- Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) [ Time Frame: 18 wks., 30 wks, 42 wks ]Semi-structured interview that assesses psychiatric symptoms, treatments, and functional outcomes in the time period that has elapsed since the previous assessment and tracks change over time.
- Child's Behavior Checklist - Parent Version (CBCL-P) [ Time Frame: 18 wks., 30 wks., 42 wks. ]Completed by parents to describe the child's behavioral and emotional difficulties. Scores reflect observed problems and level of adaptive functioning.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740726
|United States, Georgia|
|Emory Executive Park|
|Atlanta, Georgia, United States, 30329|
|Principal Investigator:||Edward Craighead, PhD||Emory University|