Genetic and Neural Predictors of Adolescent Depression

• ClinicalTrials.gov Identifier: NCT01743716
• Recruitment Status: Active, not recruiting
• First Posted: December 6, 2012
• Last Update Posted: February 25, 2020
• Sponsor: Mclean Hospital
• 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
• 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

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

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