We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genetic and Neural Predictors of Adolescent Depression

This study is currently recruiting participants.
Verified March 2016 by Randy P. Auerbach, Mclean Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743716
First Posted: December 6, 2012
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Tommy Fuss Fund
Klingenstein Third Generation Foundation
The Dana Foundation
Information provided by (Responsible Party):
Randy P. Auerbach, Mclean Hospital
  Purpose
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.

Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Towards Identification of Genetic and Neural Predictors of Adolescent Depression

Further study details as provided by Randy P. Auerbach, Mclean Hospital:

Primary Outcome Measures:
  • Neurobiological Activity in Frontostriatal and Mesolimbic Regions [ Time Frame: Baseline ]
  • Depressive Symptoms [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Adolescent participants will provide a saliva sample for DNA analysis.

Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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:

  • 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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743716


Contacts
Contact: Colin Stanton 617-855-4240 cstanton@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Colin Stanton    617-855-4240    cstanton@mclean.harvard.edu   
Principal Investigator: Randy P. Auerbach, PhD         
Principal Investigator: Diego A. Pizzagalli, PhD         
Sponsors and Collaborators
Mclean Hospital
Tommy Fuss Fund
Klingenstein Third Generation Foundation
The Dana Foundation
Investigators
Principal Investigator: Randy P. Auerbach, PhD Mclean Hospital
Principal Investigator: Diego A. Pizzagalli, PhD Mclean Hospital
  More Information

Responsible Party: Randy P. Auerbach, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01743716     History of Changes
Other Study ID Numbers: 2012P002351
First Submitted: December 4, 2012
First Posted: December 6, 2012
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Randy P. Auerbach, Mclean Hospital:
Major Depressive Disorder
MDD
depression
adolescent

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders