Major Depressive DisorderNCT01717508
Neural Components Underlying the Treatment of Adolescent Depression
A study testing Cognitive Behavioral Therapy in people with Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
- Ages 13-18 years at time of initial assessment
- Female
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- MDD, depression, major depressive disorder, adolescent
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
12 sessions of cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Other | 12 weekly sessions of cognitive behavioral therapy Receives: Behavioral: Cognitive Behavioral Therapy |
| Healthy Controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Activity
EEG and ERP measures collected during resting state and behavioral tasks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completion1 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Randy P. Auerbach, Mclean Hospital
- Investigators
- Randy P Auerbach, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717508
- Sponsor's protocol ID
- 2012P001844
- Other IDs
- 2011A053424, 2011A051965, 2010A054978, K23MH097786
- Status last verified
- Feb 2020
- First submitted
- 23 Oct 2012
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression
- ClinicalTrials.gov ID
- NCT01717508
- Acronym / sponsor ID
- 2012P001844
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, depression, major depressive disorder, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2012
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Other | Behavioral: Cognitive Behavioral Therapy12 weekly sessions of cognitive behavioral therapy |
| Healthy Controls | No intervention | – |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
- Ages 13-18 years at time of initial assessment
Key exclusion criteria (14 listed)
- Male
- Mania/Hypomania
- Current anxiety disorders [e.g., Panic Disorder (PD), Generalized Anxiety Disorder (GAD), Obsessive Compulsive Disorder (OCD)]
- Eating Disorders
- Substance Abuse/Dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy12 sessions of cognitive behavioral therapy | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
EEG Activity
Time frame: 12 weeks
EEG and ERP measures collected during resting state and behavioral tasks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randy P Auerbach, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Activity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.