Major Depressive DisorderNCT01743716
Genetic and Neural Predictors of Adolescent Depression
An observational study of Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Adult Cohort
- 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
- 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
- High Risk Female Adolescent Additional Inclusion Criterion:
- Biological daughter of participant in the MDD Mothers cohort
- Healthy Female Adolescent Additional Inclusion Criterion:
- Biological daughter of participant in the Healthy Control Mothers cohort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards Identification of Genetic and Neural Predictors of Adolescent Depression
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.
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, MDD, depression, adolescent
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobiological Activity in Frontostriatal and Mesolimbic Regions
Measured: Baseline
Depressive Symptoms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Klingenstein Third Generation Foundation, The Dana Foundation
- Responsible party
- Principal investigator, Diego Pizzagalli, Mclean Hospital
- Investigators
- Randy P. Auerbach, PhD, Principal investigator, Mclean HospitalDiego A. Pizzagalli, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743716
- Sponsor's protocol ID
- 2012P002351
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2012
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Identification of Genetic and Neural Predictors of Adolescent Depression
- ClinicalTrials.gov ID
- NCT01743716
- Acronym / sponsor ID
- 2012P002351
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, MDD, depression, adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- The Klingenstein Third Generation Foundation, The Dana Foundation
- Study start
- Apr 2013 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurobiological Activity in Frontostriatal and Mesolimbic Regions
Time frame: Baseline
Depressive Symptoms
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randy P. Auerbach, PhD principal investigator
Mclean Hospital
Diego A. Pizzagalli, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobiological Activity in Frontostriatal and Mesolimbic Regions (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.