Bipolar Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Children and teenagers with a condition called DMDD (severe mood dysregulation) or a milder form of it:

• Children aged 7 to 17 at the time of joining, with follow-up continuing until age 25
• Children who experience abnormal mood — such as ongoing anger, sadness, or irritability — present for at least half of most days, severe enough that people around them (such as parents, teachers, or peers) can notice it
• Children who react much more strongly than other children their age to upsetting situations, for example having frequent, intense temper tantrums, outbursts, or aggression toward people or property — happening on average at least three times a week (or at least once a month for the milder form)
• Children whose mood and outburst symptoms have been present for at least 12 months with no break longer than three months
• Children whose symptoms started before age 10
• Children whose symptoms are severe in at least one setting (such as home or school) and at least mild in a second setting (for the full diagnosis), or causing noticeable difficulty in at least one setting (for the milder form)

Parents of children already enrolled in this study:

• Parents who are able to complete behavioural tasks and/or brain scanning activities
• Parents who speak English

Healthy volunteer children (as comparison participants):

• Children matched to the patient group for comparison purposes
• Children who have an identified regular doctor
• Children who speak English

Healthy volunteer adults (as comparison participants):

• Adults matched to the patient group for comparison purposes
• Adults who have a normal physical and neurological health history
• Adults who have an identified regular doctor
• Adults who speak English

Children and teenagers with Major Depressive Disorder (MDD):

• Children aged 11 to 17 at the time of joining, with follow-up continuing until age 25
• Children who meet the formal diagnostic criteria for Major Depressive Disorder, meaning five or more of the following symptoms have been present together for at least two weeks, with at least one being depressed mood or loss of interest or pleasure:
  • Feeling sad, empty, or irritable most of the day, nearly every day
  • Little or no interest or enjoyment in activities they used to enjoy
  • Significant unexplained weight change or change in appetite
  • Trouble sleeping or sleeping too much, nearly every day
  • Being unusually restless or physically slowed down, nearly every day
  • Feeling very tired or having little energy nearly every day
  • Feeling worthless or excessively guilty nearly every day
  • Difficulty thinking, concentrating, or making decisions nearly every day
  • Recurrent thoughts of death or suicide
  • Symptoms that cause real difficulty in daily life at school, socially, or in other areas
  • Symptoms not caused by a substance or another medical condition
• Young people with MDD who continue into adulthood as part of the study must be receiving ongoing psychiatric care if their MDD is still active

Children and teenagers with ADHD:

• Children aged 8 to 17
• Children who currently meet the formal diagnostic criteria for ADHD
• Children who also have certain other conditions — such as anxiety disorders, past depression, oppositional defiant disorder, tic disorders, or learning and communication difficulties — may still be considered
• Children who have an identified regular doctor
• Children who speak English

Who may not be able to join:

For children with DMDD:

• Children who show key signs of bipolar disorder, such as unusually elevated or expansive mood, inflated self-esteem or grandiosity, a significantly reduced need for sleep, or a marked increase in goal-directed activity — particularly if these symptoms occur in distinct episodes lasting more than one day
• Children who meet the criteria for schizophrenia, schizoaffective disorder, a pervasive developmental disorder, or post-traumatic stress disorder (PTSD)
• Children with an IQ below 70
• Children whose symptoms are caused by drug use or a medical or neurological condition
• Children who are currently pregnant or breastfeeding
• Children who meet the criteria for alcohol or substance misuse within the past three months

For parents of children with DMDD:

• Parents with an IQ below 70
• Parents with a serious medical condition or any condition that would interfere with taking part

For healthy volunteer children:

• Children with an IQ below 70
• Children with a serious medical condition or any condition that would interfere with brain scanning (fMRI, MEG/EEG, or fNIRS), or who are pregnant or breastfeeding
• Children who have ever been diagnosed with an anxiety disorder, a mood disorder (including depression or a manic or hypomanic episode), OCD, PTSD, conduct disorder, psychosis, current thoughts of suicide, Tourette Disorder, Autism Spectrum Disorder, or ADHD
• Children who have used substances in the two months before the study, or who currently misuse substances
• Children with a history of sexual abuse
• Children who have a parent or sibling with bipolar disorder, recurrent major depression, or any disorder involving psychosis

For healthy volunteer adults:

• Adults with an IQ below 70
• Adults who are pregnant
• Adults with any past or current history of bipolar disorder, recurrent major depression, or any disorder involving psychosis

For children and teenagers with MDD:

• Children who show key signs of bipolar disorder, such as unusually elevated or expansive mood, inflated self-esteem, a significantly reduced need for sleep, or a marked increase in goal-directed activity — particularly if these occur in distinct episodes lasting more than one day
• Children who meet the criteria for schizophrenia, schizoaffective disorder, a pervasive developmental disorder, or PTSD
• Children with an IQ below 70
• Children whose symptoms are caused by drug use or a medical or neurological condition
• Children who are currently pregnant or breastfeeding
• Children who meet the criteria for alcohol or substance misuse within the past three months

For children with ADHD:

• Children with an IQ below 70
• Children who are pregnant (this specifically affects eligibility for brain scanning)
• Children with an ongoing medical illness or a neurological condition other than ADHD
• Children with any condition that would prevent them from completing research tasks
• Children who are currently experiencing major depression
• Children who have ever had a manic or hypomanic episode

Important: Always verify eligibility with the trial site directly before applying.