Genetic and Neural Predictors of Adolescent Depression
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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 |
- Neurobiological Activity in Frontostriatal and Mesolimbic Regions [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Depressive Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Adolescent participants will provide a saliva sample for DNA analysis.
| Estimated Enrollment: | 100 |
| Estimated Primary Completion Date: | June 2014 (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| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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| Contact: Casey K. Gardiner | 617-855-4240 | cgardiner@mclean.harvard.edu |
| United States, Massachusetts | |
| McLean Hospital | Not yet recruiting |
| Belmont, Massachusetts, United States, 02478 | |
| Contact: Casey K. Gardiner 617-855-4240 cgardiner@mclean.harvard.edu | |
| Principal Investigator: Randy P. Auerbach, PhD | |
| Principal Investigator: Diego A. Pizzagalli, PhD | |
| Principal Investigator: | Randy P. Auerbach, PhD | Mclean Hospital |
| Principal Investigator: | Diego A. Pizzagalli, PhD | Mclean Hospital |
More Information
No publications provided
| Responsible Party: | Randy P. Auerbach, Co-Principal Investigator, Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT01743716 History of Changes |
| Other Study ID Numbers: | 2012P002351 |
| Study First Received: | December 4, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mclean Hospital:
|
Major Depressive Disorder MDD depression adolescent |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013