Genetic and Neural Predictors of Adolescent Depression

• Conditions: Major Depressive Disorder

• Registration Number: NCT01743716
• Lead Sponsor: Mclean Hospital

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 available

Study Timeline

• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Study Start: 2013-04
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurobiological Activity in Frontostriatal and Mesolimbic Regions	Baseline
Depressive Symptoms	6 months

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States