Genetic and Neural Predictors of Adolescent Depression

NCT ID: NCT01743716

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2020-12-31

Brief Summary

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This study aims to examine the relationship between mood and brain activity in adolescent girls in order to better understand the genetic and neural predictors of adolescent depression. The participants in this study will be healthy female adolescents aged 12-14 and their mothers. They will participate for a total of six months. Adolescent participants will have three study sessions at McLean Hospital, and during two of them, their mothers will also have assessments. Adolescent assessments will include interviews, questionnaires, computer tasks, and collection of a saliva sample for genetic analyses. Their second study visit will include an fMRI scan. Parent assessments will include an interview, questionnaires, and a computer task.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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MDD Mothers

Adult women with a history of major depressive disorder (MDD) and a healthy adolescent daughter between the ages of 12-14

No interventions assigned to this group

Healthy Control Mothers

Adult women with no history of psychopathology and an adolescent daughter between the ages of 12-14

No interventions assigned to this group

High Risk Female Adolescents

Healthy female adolescents aged 12-14 with a mother in the MDD Mothers cohort

No interventions assigned to this group

Healthy Female Adolescents

Healthy female adolescents aged 12-14 with a mother in the Healthy Control Mothers cohort.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Current or past Major Depressive Disorder
* English as first language or English fluency

* No history of psychopathology
* English as first language or English fluency

* Female
* Ages 12-14
* English as first language or English fluency
* Right handed

Exclusion Criteria

Adolescent Cohort


* Past or present diagnosis of Major Depressive Disorder
* Past or present diagnosis of any anxiety disorder
* Past or present diagnosis of Bipolar Disorder
* Past or present diagnosis of ADHD
* Presence of medical or neurological illness (head injury, loss of consciousness greater than 5 minutes, seizure)
* Current use of psychotropic medication
* Presence of any contraindication for MRI:

* Cardiac pacemakers
* Metal clips on blood vessels (also called stents)
* Artificial heart valve, artificial arms, hands, legs, etc.
* Brain stimulator devices
* Implanted drug pumps
* Ear or eye implants
* Known metal fragments in eyes
* Exposure to metal filings or shrapnel (sheet metal workers, welders, and others)
* Other metallic surgical hardware in vital area
* Certain tattoos with metallic ink
* Certain IUDs containing metal
* Certain transdermal (skin) patches such as:
* NicoDerm (nicotine for tobacco dependence)
* Transderm Scop (scopolamine for motion sickness)
* Ortho Evra (birth control)

* Positive urine pregnancy test

C. High Risk Female Adolescent Additional Inclusion Criterion:

• Biological daughter of participant in the MDD Mothers cohort

D. Healthy Female Adolescent Additional Inclusion Criterion:

• Biological daughter of participant in the Healthy Control Mothers cohort
Minimum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Klingenstein Third Generation Foundation

OTHER

Sponsor Role collaborator

The Dana Foundation

OTHER

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Randy P. Auerbach

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randy P. Auerbach, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Diego A. Pizzagalli, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2012P002351

Identifier Type: -

Identifier Source: org_study_id

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