Neural Components Underlying the Treatment of Adolescent Depression

This study is currently recruiting participants.
Verified October 2013 by Mclean Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Randy P. Auerbach, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01717508
First received: October 23, 2012
Last updated: October 25, 2013
Last verified: October 2013

October 23, 2012
October 25, 2013
October 2012
June 2014   (final data collection date for primary outcome measure)
EEG Activity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
EEG and ERP measures collected during resting state and behavioral tasks
EEG Activity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
EEG and ERP measures collected during resting state and behavioral tasks
Complete list of historical versions of study NCT01717508 on ClinicalTrials.gov Archive Site
Not Provided
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Neural Components Underlying the Treatment of Adolescent Depression
Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression

The goal of the study is to examine how cognitive behavioral therapy (CBT), a common treatment for adolescent depression, affects brain functioning. Depressed adolescents will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. EEG (electroencephalography) measures brain activity by recording the electrical activity along the scalp caused by the firing of neurons within the brain. They will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes long and held once a week for 12 weeks. Before their third therapy session, participants will complete a computer task while EEG data are recorded. After completing the treatment, the participants will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording. They will also complete follow-up assessments over the phone 1, 3, and 6 months after completing the treatment.

This study will also include healthy control participants. They will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. Three weeks later, they will return to complete a behavioral task while EEG data are recorded. Twelve weeks after the initial assessment, they will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording.

The purpose of the study is to examine the impact of individual cognitive behavioral therapy (CBT) for adolescent depression on neural functioning. Specifically, the study will utilize Brent and Poling's (1997) cognitive behavioral therapy (CBT) manual (Cognitive Therapy Treatment Manual for Depressed and Suicidal Youth), and investigators will examine pre- to post- neural activity patterns for children and adolescents who receive individual CBT for depression. Electroencephalography (EEG) techniques will be utilized to assess treatment-related effects on brain activity (i.e., anterior cingulate cortex and dorsolateral prefrontal cortex functioning). Neural activity patterns will also be compared to non-depressed, healthy controls.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Behavioral: Cognitive Behavioral Therapy
12 sessions of cognitive behavioral therapy
  • Cognitive Behavioral Therapy
    12 weekly sessions of cognitive behavioral therapy
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • No Intervention: Healthy Controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
Not Provided
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria, Major Depressive Disorder Participants:

  • Ages 13-18 years at time of initial assessment
  • Female
  • Current major depressive disorder (MDD) diagnosed according to the K-SADS Axis I semi-structured interview
  • English as first language or English fluency

Exclusion Criteria, Major Depressive Disorder Participants:

  • Male
  • Mania/Hypomania
  • Current anxiety disorders [e.g., Panic Disorder (PD), Generalized Anxiety Disorder (GAD), Obsessive Compulsive Disorder (OCD)]
  • Eating Disorders
  • Substance Abuse/Dependency
  • Conduct Disorder/Antisocial Disorder
  • ADHD
  • Psychosis
  • Mental Retardation
  • Organic Brain Syndrome
  • Current Psychotherapy Treatment
  • Medical & neurological illness (head injury, loss of consciousness for more than 5 minutes, seizures)
  • Current use of psychotropic medication for treatment of MDD with the exception of SSRIs (selective serotonin reuptake inhibitors)
  • Active suicidality

Inclusion Criteria, Healthy Control Participants:

  • Ages 13-18 years at time of initial assessment
  • Female
  • English as first language or English fluency

Exclusion Criteria, Healthy Control Participants (in addition to the exclusion criteria of the MDD group):

  • Elevated depressive symptoms as assessed in phone screen
Female
13 Years to 18 Years
Yes
Contact: Colin Stanton 617-855-4240 camdl@mclean.harvard.edu
United States
 
NCT01717508
2012P001844, 2011A053424, 2011A051965, 2010A054978, K23MH097786
No
Randy P. Auerbach, Mclean Hospital
Mclean Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Randy P Auerbach, PhD Mclean Hospital
Mclean Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP