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Completed

NCT Number: NCT01717508

Neural Components Underlying the Treatment of Adolescent 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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

13 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

12 sessions of cognitive behavioral therapy

Primary outcomes

  1. EEG Activity

    Time frame: 12 weeks

    EEG and ERP measures collected during resting state and behavioral tasks

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2012
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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