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

Recruiting now

Conditions studied: Mood Disorder

In brief

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.

Key facts

Study ID

NCT00025935

Run by

National Institute of Mental Health (NIMH)

People needed

2350

Starts

2002-01-01

Last updated by the study team

2026-08-07

Who can join

Age: 7 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 3 Exclusion criteria for those with DMDD:
• 3.1 The individual exhibits any of these cardinal bipolar symptoms:
• 3.1.1 Elevated or expansive mood
• 3.1.2 Grandiosity or inflated self-esteem
• 3.1.3 Decreased need for sleep
• 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)
• 3.1.5. Has BD symptoms in distinct periods lasting more than 1 day.
• 3.2. Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD.
• 3.3. IQ< 70
• 3.4. The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition.
• 3.5. Currently pregnant or lactating
• 3.6. Meets criteria for alcohol or substance abuse with the last three months
• Exclusion of parents of children and adolescents with DMDD or subthreshold DMDD
• 1 Have an I.Q. < 70
• 2 Have any serious medical condition or condition that interferes with participation
• 2 Healthy Volunteer Exclusion criteria:
• 2.1. I.Q. < 70;
• 2.2. Any serious medical condition or condition that interferes with fMRI or MEG/EEG scanning, or fNIRS, pregnant or lactating;
• 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.
• 2.4. Substance abuse within two months prior to study participation or present substance abuse
• 2.5. History of sexual abuse.
• 2.6. Parent or sibling with Bipolar Disorder, recurrent MDD, or any disorder with psychosis.
• 2 Healthy Volunteer Adult Exclusion criteria:
• 2.1. IQ< 70
• 2.2. Pregnant

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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