search
Back to results

Neural Components Underlying the Treatment of Adolescent Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, depression, major depressive disorder, adolescent

Eligibility Criteria

13 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Cognitive Behavioral Therapy

Healthy Controls

Arm Description

12 weekly sessions of cognitive behavioral therapy

Outcomes

Primary Outcome Measures

EEG Activity
EEG and ERP measures collected during resting state and behavioral tasks

Secondary Outcome Measures

Full Information

First Posted
October 23, 2012
Last Updated
February 21, 2020
Sponsor
Mclean Hospital
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT01717508
Brief Title
Neural Components Underlying the Treatment of Adolescent Depression
Official Title
Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD, depression, major depressive disorder, adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Other
Arm Description
12 weekly sessions of cognitive behavioral therapy
Arm Title
Healthy Controls
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
12 sessions of cognitive behavioral therapy
Primary Outcome Measure Information:
Title
EEG Activity
Description
EEG and ERP measures collected during resting state and behavioral tasks
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy P Auerbach, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neural Components Underlying the Treatment of Adolescent Depression

We'll reach out to this number within 24 hrs