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Clinical Trials/NCT01743716
NCT01743716CompletedNot Applicable

Towards Identification of Genetic and Neural Predictors of Adolescent Depression

Mclean Hospital1 site in 1 country100 target enrollmentStarted: April 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Neurobiological Activity in Frontostriatal and Mesolimbic Regions

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion 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:
  • 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

Arms & Interventions

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.

Outcomes

Primary Outcomes

Neurobiological Activity in Frontostriatal and Mesolimbic Regions

Time Frame: Baseline

Depressive Symptoms

Time Frame: 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Diego Pizzagalli

Director

Mclean Hospital

Study Sites (1)

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