NCT01743716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

8.7 years

First QC Date

December 4, 2012

Last Update Submit

March 10, 2026

Conditions

Keywords

Major Depressive DisorderMDDdepressionadolescent

Outcome Measures

Primary Outcomes (2)

  • Neurobiological Activity in Frontostriatal and Mesolimbic Regions

    Baseline

  • Depressive Symptoms

    6 months

Study Arms (4)

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.

Eligibility Criteria

Age12 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Current or past Major Depressive Disorder
  • English as first language or English fluency

You may not qualify if:

  • No history of psychopathology
  • English as first language or English fluency
  • Adolescent Cohort
  • Female
  • Ages 12-14
  • English as first language or English fluency
  • Right handed
  • 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
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Adolescent participants will provide a saliva sample for DNA analysis.

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Randy P. Auerbach, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR
  • Diego A. Pizzagalli, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 4, 2012

First Posted

December 6, 2012

Study Start

April 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations