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Trial record 2 of 5350 for:    "Depressive Disorder" [DISEASE] AND Behavioral

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
Sponsor:
Information provided by (Responsible Party):
W. Edward Craighead, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Behavioral: Behavioral Activation
Drug: Fluoxetine
Enrollment 3
Recruitment Details  
Pre-assignment Details Two subjects were screen failures and were not randomized into either arm of the study.
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description 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: 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.
Period Title: Overall Study
Started 0 1
Completed 0 1
Not Completed 0 0
Arm/Group Title Behavioral Activation Fluoxetine Total
Hide Arm/Group Description 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: 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 of all reporting groups
Overall Number of Baseline Participants 0 1 1
Hide Baseline Analysis Population Description
Baseline analysis is only for the subject that completed the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
<=18 years
1
 100.0%
1
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Female
1
 100.0%
1
 100.0%
Male
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 1 participants 1 participants
1 1
1.Primary Outcome
Title Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II)
Hide Description 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.
Time Frame Baseline, 42 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: units on a scale
-45
2.Primary Outcome
Title Change in Depressive Symptoms From Baseline Based on Children's Depression Rating Scale - Revised (CDRS-R)
Hide Description Interview-based measure, completed with both the parent and child, that assesses depression severity.
Time Frame Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available for analysis.
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Improvement and Change in Symptom Severity From Baseline Based on Clinical Global Impression - Improvement and Severity (CGI-I, CGI-S)
Hide Description Clinician's rating of symptom severity and improvement since baseline.
Time Frame Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available for analysis.
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Behaviors From Baseline Based on Behavioral Activation for Depression Scale (BADS)
Hide Description Assesses behavioral changes on 4 subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.
Time Frame Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available for analysis.
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Anxiety From Baseline Based on Multidimensional Anxiety Scale for Children (MASC)
Hide Description Measures anxiety symptom severity.
Time Frame Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available for analysis.
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Suicidal Ideation Based on Suicidal Ideation Questionnaire (SIQ)
Hide Description Assesses seriousness of suicidal intent.
Time Frame Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available for analysis.
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change in Hope Based on Children's Hope Scale (CHS)
Hide Description Assesses self-perception of ability to set and work toward goals.
Time Frame Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available for analysis.
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)
Hide Description 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.
Time Frame 18 wks., 30 wks, 42 wks
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available for analysis.
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Child's Behavior Checklist - Parent Version (CBCL-P)
Time Frame 18 wks., 30 wks., 42 wks.
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available for analysis.
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Behavioral Activation Fluoxetine
Hide Arm/Group Description 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: 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.
All-Cause Mortality
Behavioral Activation Fluoxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Behavioral Activation Fluoxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Behavioral Activation Fluoxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/1 (0.00%) 
The study terminated early due to difficulties with enrolling participants.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Research Coordinator
Organization: Emory University School of Medicine
Phone: 404-727-4799
Publications:
Ritschel, L. A., Ramirez, C. L., Jones, M., & Craighead, W. (2011). Behavioral activation for depressed teens: A pilot study. Cognitive And Behavioral Practice, 18(2), 281-299. doi:10.1016/j.cbpra.2010.07.002
Responsible Party: W. Edward Craighead, Emory University
ClinicalTrials.gov Identifier: NCT01740726     History of Changes
Other Study ID Numbers: IRB00061525
CAMP-61525 ( Other Identifier: Other )
First Submitted: November 28, 2012
First Posted: December 4, 2012
Results First Submitted: March 26, 2015
Results First Posted: April 7, 2015
Last Update Posted: December 20, 2017