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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

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Behavioral Activation Drug: Fluoxetine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
Drug Information available for: Fluoxetine

Arm Intervention/treatment
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.
Other Names:
  • Behavioral Activation Therapy
  • BA

Active Comparator: Fluoxetine Drug: 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.
Other Names:
  • Prozac
  • Sarafem
  • Rapiflux
  • Selfemra




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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United States, Georgia
Emory Executive Park
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Edward Craighead, PhD Emory University

Additional Information:
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

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Responsible Party: W. Edward Craighead, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01740726     History of Changes
Other Study ID Numbers: IRB00061525
CAMP-61525 ( Other Identifier: Other )
First Posted: December 4, 2012    Key Record Dates
Results First Posted: April 7, 2015
Last Update Posted: December 20, 2017
Last Verified: March 2015

Keywords provided by W. Edward Craighead, Emory University:
Depression
Behavioral Activation
Fluoxetine
Prozac
Treatment
Therapy
Psychotherapy
Antidepressant
Intervention

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Fluoxetine
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors