Genetic and Neural Predictors of Adolescent Depression

Major Depressive Disorder Clinical Trial

Official title:

Towards Identification of Genetic and Neural Predictors of Adolescent Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01743716
• Other study ID #: 2012P002351
• Status: Active, not recruiting
• Start date: April 2013
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Mclean Hospital	The Dana Foundation, The Klingenstein Third Generation Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurobiological Activity in Frontostriatal and Mesolimbic Regions		Baseline
Primary	Depressive Symptoms		6 months