DepressionNCT03388606
Characterization and Treatment of Adolescent Depression
An observational study of Depression, run by National Institute of Mental Health (NIMH) at 3 sites in United States.
Trial summary
This research study seeks to find causes and treatments of depression in teenagers. The study goals are to increase our knowledge of treatments for depression and understand how the brain changes when teenagers have depression. Read more about this study
- Who is it for?
- Ages 11 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Growth Mindset
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,100 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Dec 2017to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 11 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A clinical population of depressed adolescents age 11-17 (inclusive)@@@
Who may be able to join
- Youths who meet DSM 5 criteria for Major Depressive Disorder (Group 1)
- Ages 11-17 at the time of enrollment in Characterization;
- Current diagnosis of DSM-5 Major Depressive Disorder (within the last six months from assessment) which are:
- Five or more of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure.
- Depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feeling sad, blue, "down in the dumps,"or empty) or observation made by others (e.g., appears tearful or about to cry). (In children and adolescents, this may present as an irritable or cranky, rather than sad, mood.)
- Markedly diminished interest or pleasure in all, or almost all, activities every day, such as no interest in hobbies, sports, or other things the person used to enjoy doing.
Show all 31Show fewer
- Significant weight loss when not dieting or weight gain (e.g., a change of more than 5 percent of body weight in a month) or decrease or increase in appetite nearly every day.
- Insomnia (inability to get to sleep or difficulty staying asleep) or hypersomnia (sleeping too much) nearly every day
- Psychomotor agitation (e.g., restlessness, inability to sit still, pacing, pulling at clothes or clothes) or retardation (e.g., slowed speech, movements, quiet talking) nearly every day
- Fatigue, tiredness, or loss of energy nearly every day (e.g., even the smallest tasks, like dressing or washing, seem difficult to do and take longer than usual).
- Feelings of worthlessness or excessive or inappropriate guilt nearly every day (e.g., ruminating over minor past failings).
- Diminished ability to think or concentrate, or indecisiveness, nearly every day (e.g., appears easily distracted, complains of memory difficulties).
- Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideas without a specific plan, or a suicide attempt or a specific plan for committing suicide
- Symptoms cause clinically significant distress or impairment in social, occupational/academic, or other important areas of functioning.
- The episode is not attributable to the physiological effects of a substance or to another medical condition.
- Adolescent Healthy Volunteers (Group 3a)
- Youth 11 to 17 years of age at time of enrollment in Characterization
- the adolescent must be competent to assent; parents must be able comprehend and provide permission for their child (consent).
- Participants will be willing to participate in NIMH IRB approved research protocols. Minors will be asked to sign assent forms and their parents will sign the consent form.
- Participants will be willing to undergo an evaluation, which may include a psychiatric interview, review of medical history (including Tanner staging for minors), and pregnancy testing.
- Speaks English.
- Have an identified primary care clinician.
- Adult Healthy Volunteers (Group 3b)
- Adults 18 to 30 years of age at time of enrollment in Characterization
- Subjects must be competent to consent.
- Participants will be willing to participate in NIMH IRB approved research protocols.
- Participants will be willing to undergo an evaluation, which may include a psychiatric interview, review of medical history, and pregnancy testing (for females).
- Speaks English.
- Has an identified primary care clinician.
- Are the biological parent or legal guardian of an enrolled adolescent (who is a healthy volunteer or has MDD) participant; Parents of those with s-MDD are historical only; none enrolled after Dec 2021.
- Those of all ages are eligible if they are a parent of a currently enrolled participant
Who cannot join
- -Exclusion Criteria for MDD patients (Group 1)
- Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, bipolar disorder, more than mild Autism Spectrum Disorder, current Anorexia Nervosa or other severe Eating Disorder.
- Intellectual disability (clinically identified or IQ < 70)
- For subjects with major depression or sub-threshold major depressive episode: Symptoms of depression are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition by self and parent report.
- Meets DSM-5 criteria for alcohol or substance use disorder (excluding tobacco and nicotine use) within the last three months. This is determined solely by clinical interview of child and parent (e.g., KSADS).
- Current active suicidal ideation (i.e., presence of intent for engaging in suicidal behaviors).
Show all 21Show fewer
- Youths with passive suicidal ideation and/or past active suicidal ideation are still eligible.
- Participants with repeated self-harm occurring in the context of inter-personal conflict.
- -Exclusion criteria for youths meeting modified DSM criteria for Subthreshold Depression (Group 2) (this cohort is historical only; previously n=200 to be enrolled; ceased enrolling this population with Amendment J (2022); none enrolled after Dec 2021):
- Intellectual disability (clinically identified or IQ < 70).
- Any serious medical condition (such as epilepsy, heart disease requiring medication) by self and parent report.
- Past or current diagnosis of a manic or hypomanic episode, major depression), schizophrenia, schizophreniform disorder, schizoaffective illness, Tourette Disorder, or Autism Spectrum Disorder, Anorexia Nervosa or other severe Eating Disorder.
- Meets DSM-5 criteria for alcohol or substance abuse within the last three months by self and parent report.
- NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.
- -Healthy volunteer youths and adults exclusion criteria:
- Intellectual disability (clinically identified or IQ < 70).
- Any serious medical condition (such as epilepsy, heart disease requiring medication) by self and parent report.
- Past or current diagnosis of any mood disorder (manic or hypomanic episode, major depression), anxiety disorder (except specific phobia), Obsessive Compulsive Disorder (OCD), Post-Traumatic Stress Disorders (PTSD), Conduct Disorder, schizophrenia, schizophreniform disorder, schizoaffective illness, Tourette Disorder, or Autism Spectrum Disorder.
- Meets DSM-5 criteria for alcohol or substance abuse within the last three months by self and parent report; for adults, past history of substance dependency or substance abuse within the last three months by self-report.
- Parents of enrolled participants (group 3) exclusion criteria:
- --Parents who are unable to understand or read English well enough to complete the study interview and tests.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
- Completed
University of Colorado
Denver, Colorado, 80220-3706
- Completed
University of Southern California
Los Angeles, California, 90033
About this study
This research study seeks to find causes and treatments of depression in teenagers. The study goals are to increase our knowledge of treatments for depression and understand how the brain changes when teenagers have depression. The study will also compare teenagers with depression to those without mental health diagnoses.
This outpatient study is recruiting participants ages 11-17 who are depressed. They must have a pediatrician or other medical provider, be medically healthy, and able to perform research tasks. They may not currently be hospitalized, psychotic or actively suicidal. Teenagers with depression are eligible even if they are taking medication.
Read more
The study begins with an evaluation that includes clinical assessment, interviews, and questionnaires.
- Visits may include paper-and-pencil and computer tests of mood, memory, and thinking; specialized computer games; and structural and brain imaging. If eligible, study participants may return several times a year for up to two years. This part of the study does not involve treatment.
- Participants may be eligible for outpatient treatment for up to 25 weeks. This includes evidenced-based "talk" therapy. Participants may choose either Interpersonal Psychotherapy for Adolescents (IPT-A) or Cognitive Behavioral Therapy (CBT). If indicated, participants may opt to receive standard medication treatments along with psychotherapy. Research includes computer tasks and brain imaging.
All clinical evaluations, research tasks and visits are free of cost. Participants are compensated for research activities. Parents and teenager must agree to the teenager s participation in research.
The study is conducted at the NIH in Bethesda, Maryland and enrolls participants from the Washington DC Metro region within 50 miles of NIH. Transportation expenses are reimbursed by NIMH.
Read the detailed description
Objective
Depression has a prevalence of 19% in the US population and close to 350 million people suffer from the disorder worldwide. The chronic course of depression and its early onset - a maximal incidence in adolescence and young adulthood - contribute to it being a leading cause of disability worldwide. Yet, compared to many other medical conditions, we know little about the mechanisms underlying depression. In recent years, reward processing has been proposed to underlie several key behavioral and neural aberrations observed in depression. This has led to the promise that targeting reward processing may lead to much needed breakthroughs in the field. In this protocol we seek to characterize and treat depression in youth by integrating methodological and conceptual approaches that specifically focus on reward processing. Patients and their families can elect to participate in standard outpatient clinical care in this protocol. Our objective is to answer four key questions:
- What is the concordance of measures of reward processing in depression over time? Measurement is fundamental to answering substantive questions in science. Our review of the literature identified gaps in the reliability of reward measurement, the concordance between measures, and a dearth of studies that employ repeated-measure designs. We propose to tackle this using a multi-method approach in a longitudinal design.
- Are reward processing aberrations in depression similar to those in other common problems of childhood, such as anxiety and irritability? Specificity - in this case establishing which reward aberrations are unique to a certain phenotype as opposed to a generic finding related to psychopathology - is important for both nosology (disease classification) and for designing rational treatments for psychiatric problems. Below, we describe how we propose to answer this question by characterizing reward processing in those with depression and comparing it to processing in those with other common psychiatric problems in youth, such as anxiety and irritability.
- How does reward processing interact with systems subserving sense of agency? As described above, decision-making is an intricate part of reward processing. It is assumed that higher-order cognitive processes, such as the sense of ownership of one's actions - referred to as sense of agency - influence reward processing. Establishing the role of such higher-order processes in depression could lead to developing treatments that boost cognition and restore reward processing in depression. Below, we propose to answer this question by testing whether inter-individual differences in sense of agency explain variation in depression via reward processing (a mediation model).
- How is reward processing affected by environmentally-generated stress?
Studies from our own group demonstrate that stress in early life has an impact on how rewards and punishers are processed in the brain several years later. Similarly, there is good evidence for the acute effects of stress on reward processing, as indicated in our recent metanalysis. And, of course, there is ample evidence for the role on how stressful events worsen symptoms of depression. The current protocol will utilize the Trier Social Stress Test, one of the best established paradigms for examining the acute impact of stress on people, to examine associations among stress responsitivity, reward function, and psychopathology. We also wish to explore more deeply the role of family environment on stress in teens with major depression. There is a substantial literature on the role of family environment in moderating or exacerbating stress in teens, and measures and methods to assess this would be important to understand its role in teen depression.
Study population
We will study three populations: (1) Healthy volunteer children and adults (HVs; n=600); (2) Participants with Major Depressive Disorder (MDD; n=500); (3) parents (biological or legal guardians) of children with MDD or HVs who are enrolled in this protocol (N=800 total as 400/200/200 respectively). Study participants will be aged 11-17 years at initial enrollment in Characterization; this is a longitudinal study and participants who turn 18 may continue in it for up to two years. Previously we enrolled 4 cohorts. Youths with Subthreshold Depression (s-MDD) (n=200 were to be enrolled; we have enrolled n=8 over the life of the protocol and no subjects with s-MDD have been enrolled after Dec 2021)
Design
This is a Characterization study that, as of 2022, includes longitudinal observation of two adolescent cohorts. HV and MDD subjects will take part in a longitudinal, observational study that involves clinical assessment, computer tasks, fMRI and MEG scanning and continue to return for up to two years. A sample of young adult HVs (18-30 years old) will also be enrolled as a comparison cohort. Those previously enrolled as subthreshold MDD (s-MDD) will be followed for up to two years (from their initial enrollment); with Amendment J, we ceased enrolling this population; no new participants with s-MDD have been enrolled since Dec, 2021. Adolescent patients who still suffer from current MDD will be offered standard outpatient care with clinically indicated treatments. During and following outpatient clinical care, participants with MDD will continue in Characterization.
Outcome measures
For Objective 1
Primary Outcomes
fMRI: Carnival Task, AX-CPT Task; Flanker Task; Mood Induction Task
AX-CPT Task, Flanker Task
For Objective 2
Primary outcomes
fMRI: Carnival Task, AX-CPT Task; Flanker Task; Mood Induction Task
Questionnaires: MFQ, ARI, SCARED, PROMIS-A-SR, PROMIS-A-PR
For Objective 3
Primary outcomes: Carnival Task, AX-CPT Task; Flanker Task; Mood Induction Task
Questionnaires: SCSC, MFQ
fMRI/MEG: Activity in prefrontal cortex and striatum in response to rewards and to events engaging cognitive control
For Objective 4
Primary outcomes: Carnival Task, AX-CPT Task; Flanker Task; Mood Induction Task
Questionnaires: MFQ, ARI, SCARED, PROMIS-A-SR, PROMIS-A-PR
Questionnaires: Family-function measures (FAD), quality of life measure (PQ-LES-Q)
Behavioral task: Five Minute Speech Sample, Parent-Child Discussion Task, SMT, Mood Induction task, Parent-Child Discussion Task (PCDT)
- Conditions
- Depression
- Being tested
- Growth Mindset
- Keywords
- Cognitive Behavior Therapy, Mood Disorder, Biomarkers, Mechanism, Major Depressive Disorder (MDD), Natural History
- Medical subject headings
- Depression, Mood Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth MindsetBehavioural
30 Minute interactive video
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with major depression | Adolescents with a current or past history of meeting full critieria for major depressive disorder Receives: Behavioral: Growth Mindset | |
| Healthy volunteer adolescents/young adults | Adolescents with no history of significant psychiatric or medical disorders (as defined in the protocol) currently or in the past. | |
| Parents of adolescent participants | biological parent or legal guardian of an enrolled adolescent (who is a healthy volunteer, has s MDD [subthreshold depression], or has MDD [Major Depressive Disorder]) participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood and Feelings Questionnaire
changes in MFQ scores over time
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start28 Dec 2017
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel S Pine, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388606
- Sponsor's protocol ID
- 180037
- Other IDs
- 18-M-0037
- Status last verified
- 20 Oct 2026
- First submitted
- 30 Dec 2017
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sadeghi N, Fors PQ, Eisner L, Taigman J, Qi K, Gorham LS, Camp CC, O'Callaghan G, Rodriguez D, McGuire J, Garth EM, Engel C, Davis M, Towbin KE, Stringaris A, Nielson DM. Mood and Behaviors of Adolescents With Depression in a Longitudinal Study Before and During the COVID-19 Pandemic. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1341-1350. doi: 10.1016/j.jaac.2022.04.004. Epub 2022 Apr 19.
PubMed 35452785Gorham LS, Sadeghi N, Eisner L, Taigman J, Haynes K, Qi K, Camp CC, Fors P, Rodriguez D, McGuire J, Garth E, Engel C, Davis M, Towbin K, Stringaris A, Nielson DM. Clinical utility of family history of depression for prognosis of adolescent depression severity and duration assessed with predictive modeling. J Child Psychol Psychiatry. 2022 Aug;63(8):939-947. doi: 10.1111/jcpp.13547. Epub 2021 Nov 30.
PubMed 34847615Keren H, Zheng C, Jangraw DC, Chang K, Vitale A, Rutledge RB, Pereira F, Nielson DM, Stringaris A. The temporal representation of experience in subjective mood. Elife. 2021 Jun 15;10:e62051. doi: 10.7554/eLife.62051.
PubMed 34128464
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Treatment of Adolescent Depression
- ClinicalTrials.gov ID
- NCT03388606
- Acronym / sponsor ID
- 180037
- Conditions
- Depression
- Keywords
- Cognitive Behavior Therapy, Mood Disorder, Biomarkers, Mechanism, Major Depressive Disorder (MDD), Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Jan 2018 (actual)
- 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 research study seeks to find causes and treatments of depression in teenagers. The study goals are to increase our knowledge of treatments for depression and understand how the brain changes when teenagers have depression. The study will also compare teenagers with depression to those without mental health diagnoses.
This outpatient study is recruiting participants ages 11-17 who are depressed. They must have a pediatrician or other medical provider, be medically healthy, and able to perform research tasks. They may not currently be hospitalized, psychotic or actively suicidal. Teenagers with depression are eligible even if they are taking medication.
The study begins with an evaluation that includes clinical assessment, interviews, and questionnaires.
- Visits may include paper-and-pencil and computer tests of mood, memory, and thinking; specialized computer games; and structural and brain imaging. If eligible, study participants may return several times a year for up to two years. This part of the study does not involve treatment.
- Participants may be eligible for outpatient treatment for up to 25 weeks. This includes evidenced-based "talk" therapy. Participants may choose either Interpersonal Psychotherapy for Adolescents (IPT-A) or Cognitive Behavioral Therapy (CBT). If indicated, participants may opt to receive standard medication treatments along with psychotherapy. Research includes computer tasks and brain imaging.
All clinical evaluations, research tasks and visits are free of cost. Participants are compensated for research activities. Parents and teenager must agree to the teenager s participation in research.
The study is conducted at the NIH in Bethesda, Maryland and enrolls participants from the Washington DC Metro region within 50 miles of NIH. Transportation expenses are reimbursed by NIMH.
Detailed description
Objective
Depression has a prevalence of 19% in the US population and close to 350 million people suffer from the disorder worldwide. The chronic course of depression and its early onset - a maximal incidence in adolescence and young adulthood - contribute to it being a leading cause of disability worldwide. Yet, compared to many other medical conditions, we know little about the mechanisms underlying depression. In recent years, reward processing has been proposed to underlie several key behavioral and neural aberrations observed in depression. This has led to the promise that targeting reward processing may lead to much needed breakthroughs in the field. In this protocol we seek to characterize and treat depression in youth by integrating methodological and conceptual approaches that specifically focus on reward processing. Patients and their families can elect to participate in standard outpatient clinical care in this protocol. Our objective is to answer four key questions:
- What is the concordance of measures of reward processing in depression over time? Measurement is fundamental to answering substantive questions in science. Our review of the literature identified gaps in the reliability of reward measurement, the concordance between measures, and a dearth of studies that employ repeated-measure designs. We propose to tackle this using a multi-method approach in a longitudinal design.
- Are reward processing aberrations in depression similar to those in other common problems of childhood, such as anxiety and irritability? Specificity - in this case establishing which reward aberrations are unique to a certain phenotype as opposed to a generic finding related to psychopathology - is important for both nosology (disease classification) and for designing rational treatments for psychiatric problems. Below, we describe how we propose to answer this question by characterizing reward processing in those with depression and comparing it to processing in those with other common psychiatric problems in youth, such as anxiety and irritability.
- How does reward processing interact with systems subserving sense of agency? As described above, decision-making is an intricate part of reward processing. It is assumed that higher-order cognitive processes, such as the sense of ownership of one's actions - referred to as sense of agency - influence reward processing. Establishing the role of such higher-order processes in depression could lead to developing treatments that boost cognition and restore reward processing in depression. Below, we propose to answer this question by testing whether inter-individual differences in sense of agency explain variation in depression via reward processing (a mediation model).
- How is reward processing affected by environmentally-generated stress?
Studies from our own group demonstrate that stress in early life has an impact on how rewards and punishers are processed in the brain several years later. Similarly, there is good evidence for the acute effects of stress on reward processing, as indicated in our recent metanalysis. And, of course, there is ample evidence for the role on how stressful events worsen symptoms of depression. The current protocol will utilize the Trier Social Stress Test, one of the best established paradigms for examining the acute impact of stress on people, to examine associations among stress responsitivity, reward function, and psychopathology. We also wish to explore more deeply the role of family environment on stress in teens with major depression. There is a substantial literature on the role of family environment in moderating or exacerbating stress in teens, and measures and methods to assess this would be important to understand its role in teen depression.
Study population
We will study three populations: (1) Healthy volunteer children and adults (HVs; n=600); (2) Participants with Major Depressive Disorder (MDD; n=500); (3) parents (biological or legal guardians) of children with MDD or HVs who are enrolled in this protocol (N=800 total as 400/200/200 respectively). Study participants will be aged 11-17 years at initial enrollment in Characterization; this is a longitudinal study and participants who turn 18 may continue in it for up to two years. Previously we enrolled 4 cohorts. Youths with Subthreshold Depression (s-MDD) (n=200 were to be enrolled; we have enrolled n=8 over the life of the protocol and no subjects with s-MDD have been enrolled after Dec 2021)
Design
This is a Characterization study that, as of 2022, includes longitudinal observation of two adolescent cohorts. HV and MDD subjects will take part in a longitudinal, observational study that involves clinical assessment, computer tasks, fMRI and MEG scanning and continue to return for up to two years. A sample of young adult HVs (18-30 years old) will also be enrolled as a comparison cohort. Those previously enrolled as subthreshold MDD (s-MDD) will be followed for up to two years (from their initial enrollment); with Amendment J, we ceased enrolling this population; no new participants with s-MDD have been enrolled since Dec, 2021. Adolescent patients who still suffer from current MDD will be offered standard outpatient care with clinically indicated treatments. During and following outpatient clinical care, participants with MDD will continue in Characterization.
Outcome measures
For Objective 1
Primary Outcomes
fMRI: Carnival Task, AX-CPT Task; Flanker Task; Mood Induction Task
AX-CPT Task, Flanker Task
For Objective 2
Primary outcomes
fMRI: Carnival Task, AX-CPT Task; Flanker Task; Mood Induction Task
Questionnaires: MFQ, ARI, SCARED, PROMIS-A-SR, PROMIS-A-PR
For Objective 3
Primary outcomes: Carnival Task, AX-CPT Task; Flanker Task; Mood Induction Task
Questionnaires: SCSC, MFQ
fMRI/MEG: Activity in prefrontal cortex and striatum in response to rewards and to events engaging cognitive control
For Objective 4
Primary outcomes: Carnival Task, AX-CPT Task; Flanker Task; Mood Induction Task
Questionnaires: MFQ, ARI, SCARED, PROMIS-A-SR, PROMIS-A-PR
Questionnaires: Family-function measures (FAD), quality of life measure (PQ-LES-Q)
Behavioral task: Five Minute Speech Sample, Parent-Child Discussion Task, SMT, Mood Induction task, Parent-Child Discussion Task (PCDT)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescents with major depression | – | Behavioral: Growth MindsetAdolescents with a current or past history of meeting full critieria for major depressive disorder |
| Healthy volunteer adolescents/young adults | – | –Adolescents with no history of significant psychiatric or medical disorders (as defined in the protocol) currently or in the past. |
| Parents of adolescent participants | – | –biological parent or legal guardian of an enrolled adolescent (who is a healthy volunteer, has s MDD [subthreshold depression], or has MDD [Major Depressive Disorder]) participant |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A clinical population of depressed adolescents age 11-17 (inclusive)@@@
Key inclusion criteria (31 listed)
- Youths who meet DSM 5 criteria for Major Depressive Disorder (Group 1)
- Ages 11-17 at the time of enrollment in Characterization;
- Current diagnosis of DSM-5 Major Depressive Disorder (within the last six months from assessment) which are:
- Five or more of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure.
- Symptoms cause clinically significant distress or impairment in social, occupational/academic, or other important areas of functioning.
Key exclusion criteria (21 listed)
- -Exclusion Criteria for MDD patients (Group 1)
- Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, bipolar disorder, more than mild Autism Spectrum Disorder, current Anorexia Nervosa or other severe Eating Disorder.
- Intellectual disability (clinically identified or IQ < 70)
- For subjects with major depression or sub-threshold major depressive episode: Symptoms of depression are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition by self and parent report.
- Meets DSM-5 criteria for alcohol or substance use disorder (excluding tobacco and nicotine use) within the last three months. This is determined solely by clinical interview of child and parent (e.g., KSADS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth Mindset30 Minute interactive video | Behavioural | Adolescents with major depression |
Primary outcome
Mood and Feelings Questionnaire
Time frame: ongoing
changes in MFQ scores over time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 35452785Sadeghi N, Fors PQ, Eisner L, Taigman J, Qi K, Gorham LS, Camp CC, O'Callaghan G, Rodriguez D, McGuire J, Garth EM, Engel C, Davis M, Towbin KE, Stringaris A, Nielson DM. Mood and Behaviors of Adolescents With Depression in a Longitudinal Study Before and During the COVID-19 Pandemic. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1341-1350. doi: 10.1016/j.jaac.2022.04.004. Epub 2022 Apr 19.
- Derived from this study: PubMed 34847615Gorham LS, Sadeghi N, Eisner L, Taigman J, Haynes K, Qi K, Camp CC, Fors P, Rodriguez D, McGuire J, Garth E, Engel C, Davis M, Towbin K, Stringaris A, Nielson DM. Clinical utility of family history of depression for prognosis of adolescent depression severity and duration assessed with predictive modeling. J Child Psychol Psychiatry. 2022 Aug;63(8):939-947. doi: 10.1111/jcpp.13547. Epub 2021 Nov 30.
- Derived from this study: PubMed 34128464Keren H, Zheng C, Jangraw DC, Chang K, Vitale A, Rutledge RB, Pereira F, Nielson DM, Stringaris A. The temporal representation of experience in subjective mood. Elife. 2021 Jun 15;10:e62051. doi: 10.7554/eLife.62051.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Daniel S Pine, M.D. principal investigator
National Institute of Mental Health (NIMH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by National Institute of Mental Health (NIMH) at 3 sites 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?
The sponsor lists 31 inclusion and 21 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel S Pine, M.D. ((301) 594-1318, daniel.pine@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood and Feelings Questionnaire (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388606, which also lists 3 linked publications.
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 26 Oct 2026.