Neural Components Underlying the Treatment of Adolescent Depression

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • EEG Activity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    EEG and ERP measures collected during resting state and behavioral tasks


Estimated Enrollment: 112
Study Start Date: October 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cognitive Behavioral Therapy
12 weekly sessions of cognitive behavioral therapy
Behavioral: Cognitive Behavioral Therapy
12 sessions of cognitive behavioral therapy
No Intervention: Healthy Controls

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717508

Contacts
Contact: Colin Stanton 617-855-4240 camdl@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Colin Stanton    617-855-4240    camdl@mclean.harvard.edu   
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Randy P Auerbach, PhD Mclean Hospital
  More Information

No publications provided

Responsible Party: Randy P. Auerbach, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01717508     History of Changes
Other Study ID Numbers: 2012P001844, 2011A053424, 2011A051965, 2010A054978, K23MH097786
Study First Received: October 23, 2012
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
MDD
depression
major depressive disorder
adolescent

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014