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

NCT01740726 | Terminated Results DMC

• 2 other identifiers: IRB00061525CAMP-61525
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Depression; Behavioral Activation; Fluoxetine; Prozac; Treatment; Therapy; Psychotherapy; Antidepressant; Intervention

Outcome Measures

Primary Outcomes (2)

• Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II)

  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.

  Baseline, 42 weeks

• Change in Depressive Symptoms From Baseline Based on Children's Depression Rating Scale - Revised (CDRS-R)

  Interview-based measure, completed with both the parent and child, that assesses depression severity.

  Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

Secondary Outcomes (5)

• Overall Improvement and Change in Symptom Severity From Baseline Based on Clinical Global Impression - Improvement and Severity (CGI-I, CGI-S)

  Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

• Change in Behaviors From Baseline Based on Behavioral Activation for Depression Scale (BADS)

  Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

• Change in Anxiety From Baseline Based on Multidimensional Anxiety Scale for Children (MASC)

  Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

• Change in Suicidal Ideation Based on Suicidal Ideation Questionnaire (SIQ)

  Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

• Change in Hope Based on Children's Hope Scale (CHS)

  Baseline, 9 wks., 18 wks., 30 wks., 42 wks.

Other Outcomes (2)

• Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)

  18 wks., 30 wks, 42 wks

• Child's Behavior Checklist - Parent Version (CBCL-P)

  18 wks., 30 wks., 42 wks.

Study Arms (2)

Behavioral Activation

EXPERIMENTAL

Behavioral: Behavioral Activation

Fluoxetine

ACTIVE COMPARATOR

Drug: Fluoxetine

Interventions

Behavioral Activation BEHAVIORAL

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.

Also known as: Behavioral Activation Therapy, BA

Behavioral Activation

Fluoxetine DRUG

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.

Also known as: Prozac, Sarafem, Rapiflux, Selfemra

Fluoxetine

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female adolescents ages 13-17
• Current diagnosis of Major Depressive Disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL), Children's Depression Rating Scale (CDRS-R) raw score \> 45 (T-score \> 65) at baseline
• Estimated full scale IQ \> 80 as determined by the Wechsler Intelligence Scale for Children (WISC)
• Able to receive outpatient care
• Willing to discontinue other psychosocial treatments
• Not taking psychotropic medications in the one month prior to consent, with the exception of psychostimulant medication prescribed for the treatment of attention-deficit/hyperactivity disorder (ADHD)

You may not qualify if:

• Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis not otherwise specified
• Current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, obsessive-compulsive disorder, or autism-spectrum disorders
• Taking psychotropic medications prior to entry
• Estimated IQ \< 80
• Alcohol/drug dependence or abuse within the last 3 months
• Potential/confirmed neurological disorder or epilepsy
• Claustrophobia
• Presence of a medical condition that precludes fMRI
• Endorsement of imminent and serious suicidality
• Medical conditions for which treatment with fluoxetine is contraindicated or that take precedence over the presence of major depressive disorder (MDD)
• Pregnancy

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Executive Park

Atlanta, Georgia, 30329, United States

Location

Related Publications (2)

• 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

  BACKGROUND

• Jacob M, Keeley ML, Ritschel L, Craighead WE. Behavioural activation for the treatment of low-income, African American adolescents with major depressive disorder: a case series. Clin Psychol Psychother. 2013 Jan-Feb;20(1):87-96. doi: 10.1002/cpp.774. Epub 2011 Aug 22.

  PMID: 21861272 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

The study terminated early due to difficulties with enrolling participants.

Results Point of Contact

• Title: Research Coordinator
• Organization: Emory University School of Medicine

sean.carey@emory.edu

404-727-4799

Study Officials

• Edward Craighead, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 20, 2017
• Results First Posted: April 7, 2015

Record last verified: 2015-03

Locations

US (1)