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NCT00025935 · National Institute of Mental Health (NIMH)

Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder

What this study is about

This study seeks to learn more about the symptoms of severe mood dysregulation in children and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (SMD) display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums).

View original scientific description

This study seeks to learn more about the symptoms of severe mood dysregulation in children and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (SMD) display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums). Researchers will describe the moods and behaviors of children with these symptoms and use specialized testing and brain imaging to learn about the brain changes associated with this disorder....

Interventions

DRUG

Lithium

Primary outcome measures

To examine between-group differences in clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables

Time frame: 20 years

Individuals with full or subthreshold DMDD and/or MDD, ADHD, anxiety (see protocol 00-M-0192), and healthy volunteers (see protocol 00-M-0198).

To examine associations between irritability and clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables

Time frame: 20 years

Individuals with full or subthreshold DMDD and/or MDD, ADHD, anxiety (see protocol 00-M-0192), and healthy volunteers (see protocol 00-M-0198).

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Parents of children and adolescents with DMDD or subthreshold DMDD enrolled in 02-M-0021 2.1.1. Are capable of performing behavioral tasks and/or scanning. 2.1.2. Speaks English
  • Healthy Volunteer (Control) Children 3.1.1. Control subjects will be group matched to the patients. 3.1.2. Have an identified primary care physician. 3.1.3. Speaks English
  • Healthy Volunteer Adults 4.1.1 Control subjects will be group matched to the patients. 4.1.2. They will have normal physical and neurological examinations by history or checklist 4.1.3. Have an identified primary care physician. 4.1.4 Speaks English
  • Children with Major Depressive Disorder (MDD) Inclusion criteria (all must be met): 5.1.1 Ages 11-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25. 5.1.2. DSM-IV or DSM-5 Major Depressive Disorder 5.1.2.1 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. 5.1.2.1.1 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.) 5.1.2.1.2 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. 5.1.2.1.3. 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. 5.1.2.1.4. Insomnia (inability to get to sleep or difficulty staying asleep) or hypersomnia (sleeping too much) nearly every day 5.1.2.1.5. 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 5.1.2.1.6. 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). 5.1.2.1.7. Feelings of worthlessness or excessive or inappropriate guilt nearly every day (e.g., ruminating over minor past failings). 5.1.2.1.8. Diminished ability to think or concentrate, or indecisiveness, nearly every day (e.g. appears easily distracted, complains of memory difficulties). 5.1.2.1.9. 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 5.1.2.1.10 Symptoms cause clinically significant distress or impairment in social, occupational/academic, or other important areas of functioning. 5.1.2.1.11. The episode is not attributable to the physiological effects of a substance or to another medical condition. 5.1.3. Youth with MDD who are continuing in research as adults must also be receiving psychiatric care for their MDD, if it is ongoing
  • Children with Attention-Deficit/Hyperactivity Disorder (ADHD) 6.1.1. Age 8-17 6.1.2. Currently meets DSM-IV or DSM-5 criteria for ADHD 6.1.3. Subjects with other primary psychiatric disorders including anxiety disorders, dysthymic disorder, past major depression, oppositional defiant disorder, tic disorders, and the learning, communication, and elimination disorders may be accepted 6.1.4. Have an identified primary care physician. 6.1.5. Speaks English

Exclusion criteria

  • 3 Exclusion criteria for those with DMDD: 1.3.1 The individual exhibits any of these cardinal bipolar symptoms: 1.3.1.1 Elevated or expansive mood 1.3.1.2 Grandiosity or inflated self-esteem 1.3.1.3 Decreased need for sleep 1.3.1.4 Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences) 1.3.1.5. Has BD symptoms in distinct periods lasting more than 1 day. 1.3.2. Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD. 1.3.3. IQ\< 70 1.3.4. The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition. 1.3.5. Currently pregnant or lactating 1.3.6. Meets criteria for alcohol or substance abuse with the last three months 2\. Exclusion of parents of children and adolescents with DMDD or subthreshold DMDD 2.1 Have an I.Q. \< 70 2.2 Have any serious medical condition or condition that interferes with participation 3.2 Healthy Volunteer Exclusion criteria: 3.2.1. I.Q. \< 70; 3.2.2. Any serious medical condition or condition that interferes with fMRI or MEG/EEG scanning, or fNIRS, pregnant or lactating; 3.2.3. Past or current diagnosis of any anxiety disorder (panic disorder, GAD, Separation Anxiety Disorder, Social Phobia), mood disorder (manic or hypomanic episode, major depression), OCD, PTSD, Conduct Disorder, psychosis, current suicidal ideation, Tourette Disorder, Autism Spectrum Disorder or ADHD. 3.2.4. Substance abuse within two months prior to study participation or present substance abuse 3.2.5. History of sexual abuse. 3.2.6. Parent or sibling with Bipolar Disorder, recurrent MDD, or any disorder with psychosis. 4.2 Healthy Volunteer Adult Exclusion criteria: 4.2.1. IQ\< 70 4.2.2. Pregnant 4.2.3. Any past or current history of Bipolar Disorder (any manic or hypomanic episode), recurrent MDD, or any disorder with psychosis 5.3 Exclusion criteria for those with MDD: 5.3.1 The individual exhibits any of these cardinal bipolar symptoms: 5.3.1.1 Elevated or expansive mood 5.3.1.2 Grandiosity or inflated self-esteem 5.3.1.3 Decreased need for sleep 5.3.1.4 Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences) 5.3.1.5. Has BD symptoms in distinct periods lasting more than 1 day. 5.3.2. Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD. 5.3.3. IQ\< 70 5.3.4. The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition. 5.3.5. Currently pregnant or lactating 5.3.6. Meets criteria for alcohol or substance abuse with the last three months 6.2. Exclusion criteria for those with ADHD: 6.2.1. IQ\<70 6.2.2. Pregnancy (excludes for scanning only) 6.2.3. Ongoing medical illness or neurological disorder other than ADHD 6.2.4. Any condition that would interfere with the participants' ability to perform research tasks 6.2.5. Current Major Depression 6.2.6. Any past or present manic or hypomanic episode

Where

  • Bethesda, Maryland

Related conditions & keywords

Mood DisorderNeuroimagingConduct DisorderChildren and AdolescentsAffective NeuroscienceNatural HistoryBehavioral DysregulationBehaviorChildrenAdolescentHealthy VolunteerHVNormal Control

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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If you're searching for Mood Disorder treatment in Bethesda, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Bethesda and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Mood Disorder. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Maryland
Now Enrolling
Up to 2350 participants
Quick Start
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Why Consider a Clinical Trial for Mood Disorder?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Mood Disorder

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Mood Disorder Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT00025935. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.