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Genetic and Neural Predictors of Adolescent Depression

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ClinicalTrials.gov Identifier: NCT01743716
Recruitment Status : Active, not recruiting
First Posted : December 6, 2012
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
The Klingenstein Third Generation Foundation
The Dana Foundation
Information provided by (Responsible Party):
Randy P. Auerbach, Mclean Hospital

Study Description
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Brief Summary:
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.

Condition or disease
Major Depressive Disorder

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Towards Identification of Genetic and Neural Predictors of Adolescent Depression
Actual Study Start Date : April 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
MDD Mothers
Adult women with a history of major depressive disorder (MDD) and a healthy adolescent daughter between the ages of 12-14
Healthy Control Mothers
Adult women with no history of psychopathology and an adolescent daughter between the ages of 12-14
High Risk Female Adolescents
Healthy female adolescents aged 12-14 with a mother in the MDD Mothers cohort
Healthy Female Adolescents
Healthy female adolescents aged 12-14 with a mother in the Healthy Control Mothers cohort.


Outcome Measures
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Primary Outcome Measures :
  1. Neurobiological Activity in Frontostriatal and Mesolimbic Regions [ Time Frame: Baseline ]
  2. Depressive Symptoms [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Adolescent participants will provide a saliva sample for DNA analysis.

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will include two adult and two adolescent cohorts. The adult cohort includes two different groups of mothers: (a) MDD Mothers: Mothers with current or past major depressive disorder and (b) Healthy Control Mothers: Mothers with no history of psychopathology. The female adolescent cohorts are as follows: (c) High Risk Female Adolescents: Healthy female adolescents aged 12-14 with a mother reporting past or current MDD, (d) Healthy Female Adolescents: Healthy female adolescents aged 12-14 with a mother reporting no history of psychopathology.
Criteria

Adult Cohort

A. MDD Mothers Cohort Inclusion Criteria:

  • Current or past Major Depressive Disorder
  • English as first language or English fluency
  • Biological daughter who meets inclusion/exclusion criteria for High Risk Female Adolescent

B. Healthy Control Mothers Cohort Inclusion Criteria:

  • No history of psychopathology
  • English as first language or English fluency
  • Biological daughter who meets inclusion/exclusion criteria for Healthy Female Adolescent

Adolescent Cohort

General Inclusion Criteria for Adolescent Cohorts:

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

General Exclusion Criteria for Adolescent Cohorts:

  • 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743716


Locations
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
The Klingenstein Third Generation Foundation
The Dana Foundation
Investigators
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Principal Investigator: Randy P. Auerbach, PhD Mclean Hospital
Principal Investigator: Diego A. Pizzagalli, PhD Mclean Hospital
More Information
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Responsible Party: Randy P. Auerbach, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01743716    
Other Study ID Numbers: 2012P002351
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by Randy P. Auerbach, Mclean Hospital:
Major Depressive Disorder
MDD
depression
adolescent
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders