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Genetic and Neural Predictors of Adolescent Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 4, 2012
First Posted Date December 6, 2012
Last Update Posted Date February 25, 2020
Actual Study Start Date April 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2012)
  • Neurobiological Activity in Frontostriatal and Mesolimbic Regions [ Time Frame: Baseline ]
  • Depressive Symptoms [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic and Neural Predictors of Adolescent Depression
Official Title Towards Identification of Genetic and Neural Predictors of Adolescent Depression
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Adolescent participants will provide a saliva sample for DNA analysis.
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.
Condition Major Depressive Disorder
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: December 4, 2012)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: Female
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01743716
Other Study ID Numbers 2012P002351
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Randy P. Auerbach, Mclean Hospital
Study Sponsor Mclean Hospital
Collaborators
  • The Klingenstein Third Generation Foundation
  • The Dana Foundation
Investigators
Principal Investigator: Randy P. Auerbach, PhD Mclean Hospital
Principal Investigator: Diego A. Pizzagalli, PhD Mclean Hospital
PRS Account Mclean Hospital
Verification Date February 2020