ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 378 for:    depression OR mood disorders OR depressive disorder OR bipolar depression OR postpartum depression OR child depression OR adolescent depression OR geriatric depression OR psychotic depression OR anhedonia OR dysphoria OR minor depression | Recruiting, Not yet recruiting, Available Studies | NIH
Previous Study | Return to List | Next Study

Characterization and Treatment of Adolescent Depression

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.
ClinicalTrials.gov Identifier: NCT03388606
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Brief Summary:

Background:

Almost 20% of Americans have depression. It is a leading cause of disability because it is chronic and it starts early. The highest incidence is among adolescents and young adults. But researchers don t know much about how depression occurs. It may be linked to reward processing.

Objective:

To characterize and treat depression in youth by focusing on reward processing.

Eligibility:

People ages 11-17 with major depressive disorder or subthreshold depression

Healthy volunteers ages 11-17

Design:

Participants will be screened with interviews and questionnaires. They will have memory, thinking, and concentration tests. They may have a urine pregnancy test or have photos or videos taken.

At the initial visit, participants will:

  • Repeat screening tests
  • Watch an interactive video about mood problems and anxiety
  • Have functional MRI. Participants will lie in a metal cylinder in a magnetic field. They will do study tasks on a screen.
  • Look at pictures to evoke happiness, sadness, or fear and get money for making certain choices. Parents can check the pictures before the children see them.
  • Have brain and eye activity monitored
  • Do tasks in a virtual reality environment
  • Wear an activity monitor

Participants will get phone prompts at home to ask about their mood.

Participants will have several follow-up visits the first year, then 1 a year until they are 25. They will repeat some tests above.

Some participants with depression will have more visits before and after they have treatment. They will do some of the tests above plus drug testing. Participants and their parents will talk with a nurse, social worker, or psychologist. They will have practice work between visits.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Growth Mindset Behavioral: Comparison Session Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Characterization and Treatment of Adolescent Depression
Actual Study Start Date : December 28, 2017
Estimated Primary Completion Date : August 20, 2020
Estimated Study Completion Date : August 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
GMI (Growth Mindset Intervention)
Behavioral: Growth Mindset
30 Minute interactive video

Sham Comparator: 2
Interactive video on emotion expression, structurally equivalent to GMI
Behavioral: Comparison Session
Interactive video on emotion expression, structurally equivalent to GMI




Primary Outcome Measures :
  1. Moody and Feelings Questionnaire [ Time Frame: 2 weeks ]


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:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Youths who meet DSM 5 criteria for Major Depressive Disorder (Group 1)

Inclusion criteria for Youth with MDD (all must be met):

  • 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 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.
      • 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.
  • Added criteria for Children with MDD entering inpatient treatment. In addition to criteria above, the youth:

    • Is failing his/her treatment as defined as a current CGAS score less than or equal to 60
    • If the child has a psychiatrist, the child s psychiatrist or treater agrees that the child s response to his/her current treatment makes it clinically appropriate to change the child s current treatment
    • On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e. CGI-I greater than 2)
  • Added criteria for Children with MDD entering outpatient treatment. In addition to criteria in above, the youth:

    ---Meets criteria for on-going MDD

  • Youths who meet modified DSM criteria for Subthreshold Depression (Group 2)

    -- Inclusion criteria for subthreshold depressive disorder are:

    • Ages 11-17 at the time of enrollment in Characterization;
    • An episode of depressed mood or loss of interest or pleasure lasting at least 1 week plus
    • At least two of the seven other DSM-5-associated symptoms for major depression
    • Occurring in the last six months.
  • Healthy volunteer youths (Group 3)

    • Youth 11 to 17 years of age at time of enrollment in Characterization
    • Subjects must be competent to assent; parents must be able comprehend and provide permission for their child (consent).
    • Youth 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.
    • Subjects willing to undergo an evaluation which may include a psychiatric interview, review of medical history (including Tanner staging for minors), pregnancy testing.
    • Speaks English
    • Has an identified primary care clinician

EXCLUSION CRITERIA: (All patients)

-Exclusion Criteria for MDD patients (Group 1)

  • Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, bipolar disorder, more than mild Autism Spectrum Disorder, Anorexia Nervosa or other severe Eating Disorder.
  • Intellectual disability (clinically identified or IQ less than 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.
  • Currently pregnant or lactating by self and parent report and urine pregnancy test.
  • 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).

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.
  • NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.

    -Exclusion criteria for youths meeting modified DSM criteria for Subthreshold Depression (Group 2):

  • Intellectual disability (clinically identified or IQ less than 70).
  • Any serious medical condition (such as epilepsy, heart disease requiring medication) by self and parent report.
  • Currently pregnant or lactating by self and parent report and urine pregnancy test
  • 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.
  • Parent or sibling with a history of any disorder with psychosis.
  • NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.

    -Healthy volunteer youth exclusion criteria:

  • Intellectual disability (clinically identified or IQ less than 70).
  • Any serious medical condition (such as epilepsy, heart disease requiring medication) by self and parent report.
  • Currently pregnant or lactating by self and parent report and urine pregnancy test
  • 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 criteria for subthreshold depression (as defined above)
  • Meets DSM-5 criteria for alcohol or substance abuse within the last three months by self and parent report.
  • Parent or sibling with a history of any disorder with psychosis.
  • NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.

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): NCT03388606


Contacts
Contact: Argyris Stringaris, M.D. (301) 443-8019 argyris.stringaris@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Argyris Stringaris, M.D. National Institute of Mental Health (NIMH)

Additional Information:
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT03388606     History of Changes
Other Study ID Numbers: 180037
18-M-0037
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: April 19, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Mood Disorder
Teenagers
Mechanism

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