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Children: Irritability

Join a Research Study: Enrolling nationally from around the Country

A Study of Brain Function and Symptoms in Children with Severe Mood Dysregulation

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.

Study participation begins with an initial outpatient evaluation that lasts one day. Then, testing and brain imaging are completed at two-three day outpatient visits which occur every two years until participants reach age 25. Phone contact occurs every six months in between visits.

Descriptive/Longitudinal Study: When children have severe mood dysregulation (SMD), do their brains work differently than those of other children? How do their symptoms change as the children grow up?

After a preliminary phone interview, participants may be invited to NIMH for an on-site assessment. Children must be in treatment with a psychiatrist or provider, and/or medically healthy and not currently hospitalized, psychotic or suicidal.

A principal focus of the research is how mood, behavior, and brain development of children with severe mood dysregulation (SMD) change over time. Study procedures at the two-three day visits may include questionnaires and interviews; paper-and-pencil and computer tests of mood, memory, and thinking; specialized computer games; and structural and functional Magnetic Resonance Imaging (MRI) scans. These visits occur every two years until age 25. Children continue in treatment with a provider or psychiatrist in their community. This study does not involve treatment medications.

To find out if you qualify, email NIMH or call 1-301-496-8381 [TTY: 1-866-411-1010].

Join a Research Study: Irritability

Clinical Trial of Citalopram and Methylphenidate in Severe Mood Dysregulation

This study is testing the effectiveness of methylphenidate plus citalopram vs. methylphenidate plus placebo for decreasing irritability in children with severe mood dysregulation (SMD). Children with 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).

Children ages seven to 17 with SMD may be eligible to participate in this 12- to 15-week inpatient or outpatient study. This study has four phases. During Phase I participants are gradually withdrawn from all current psychotropic medications. Phase II is a one-week psychotropic medication-free period. During Phase III, which lasts two weeks, participants are treated with methylphenidate alone. Phase IV lasts for eight weeks. During this time, participants continue methylphenidate treatment and are randomly assigned to also receive either citalopram or placebo.

At the end of the study, those who received methylphenidate plus placebo will have the opportunity to receive methylphenidate plus active citalopram if clinically appropriate.

All procedures and medications associated with the research are provided at no cost to participants, and transportation expenses are reimbursed by NIMH. Schooling will be provided while on the inpatient unit or in day treatment.

To find out if you qualify, email NIMH or call 1-301-496-8381 [TTY: 1-866-411-1010].

Join a Research Study: Irritability

Psychological Treatments for Youth with Severe Irritability

This is a study to find out whether non-drug interventions can be effective for children who are very irritable. The two interventions are Cognitive Behavioral Therapy (CBT) (a kind of “talking therapy”) and Interpretation Bias Training (IBT) (a computer-based training). The purpose of this research is to learn whether these interventions will decrease irritability and temper outbursts in children with Disruptive Mood Dysregulation Disorder (DMDD). Compared to their peers, children with DMDD display chronic anger and irritability. They often have extreme responses, such as severe temper tantrums, when they become frustrated or when parents or teachers set limits on their behavior. Children ages 8 to 17 with DMDD who live within 50 miles of Bethesda Marylandmay be eligible to participate in this study. Children do not need to be on medication to participate in this study. Those who are currently receiving medications will remain on them throughout the study.

Participants may choose to participate in only CBT, only IBT, or IBT followed by CBT.

During CBT, children and their families participate in 12-16 outpatient sessions over up to 16 weeks. The study seeksto evaluate techniques and strategies to manage and reduce irritability and temper outbursts. The treatment includes practicing strategies at home between treatment sessions.

IBT is a 14-15 week computer-based learning program. It has three phases, each of which includes some outpatient visits and some computer use at home.

  • In Phase I, children participate in 18 days of initial training. Some of these training sessions are done in the clinic at the NIH and some are done at home. There are two different trainings—“active” and “not active.” The child’s assignment to “active” or “not-active” training in this phase is made randomly—like flipping a coin.
  • In Phase II children come to the NIH weekly eight times and complete training sessions. During this time, they continue to receive the same “active” or “not-active” training.
  • In Phase III, which lasts for 18 days, all children receive “active” training, and training sessions are done in the NIH clinic and at home, in the same manner as Phase I. Children and their families will be informed about which training group they were in when all the participants have completed the entire study.

All procedures associated with the research are provided at no cost to participants, and transportation expenses are reimbursed by NIMH.

To find out if you qualify, email NIMH or call 1-301-496-8381 [TTY: 1-866-411-1010].