Genetic and Neural Predictors of Adolescent Depression

Towards Identification of Genetic and Neural Predictors of Adolescent Depression

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.

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neurobiological Activity in Frontostriatal and Mesolimbic Regions	Baseline
Depressive Symptoms	6 months

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: The Klingenstein Third Generation Foundation; The Dana Foundation
• Investigators: Principal Investigator: Diego A. Pizzagalli, PhD, McLean Hospital; Principal Investigator: Randy P. Auerbach, PhD, McLean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: depression; adolescent; MDD; Major Depressive Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2012P002351