Study on Investigational Medication for Depressive Episodes in Youth with Bipolar Disorder
Leslie Hulvershorn, MD, MSc
Primary Investigator
Brief description of study
This study investigates the use of an investigational medication for treating depressive episodes in young people aged 10 to 17 years with Bipolar I Disorder. The study aims to see if the investigational medication is safe and works well in young people.
Bipolar I Disorder is a mental health condition that causes extreme mood swings, including emotional highs (mania or hypomania) and lows (depression).
Detailed description of study
- Who can participate: Children and teens aged 10 to 17 years with Bipolar Disorder can participate. Participants must have had at least one manic episode and be in a current depressive episode lasting more than 2 weeks but less than 12 months. They must be able to swallow the study medication and have a parent or guardian who can accompany them to study visits.
- Study details: Participants will take either the investigational medication or a placebo. They will need to attend regular study visits for health checks and assessments. The placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
- Study timelines: The study will last 13 weeks.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Bipolar I Disorder, Riley
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Age: 10 years - 17 years
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Gender: All
Inclusion Criteria:
- Male or female child 10 to 17 years of age
- The child has a primary diagnosis of bipolar I disorder (most recent episode depressed, with or without psychotic features)
- The duration of the current depressive episode is more than 2 weeks and less than 12 months.
- The child has a lifetime history of at least one manic episode
- The child's Parent or legal representative must be capable of giving signed informed consent
- The child must be capable to provide a signed Informed assent
- The child must be able and willing to follow study instructions
- The child's parents or legal representatives are willing and able to be responsible for safety monitoring of the subject, provide information about the child’s condition, oversee administration of study intervention, and accompany the subject to all study visits.
- The child is able to swallow the study medication
Exclusion Criteria:
- The child has a primary diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder.
- The child has a history of any substance-related disorder (except caffeine- and tobacco-related) in the past 3 months.
- The child has history of serotonin syndrome or neuroleptic malignant syndrome.
- The child has four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) in the past 12 months.
- The child has diagnosis of intellectual disability.
- The child has psychiatric symptoms possibly secondary to any other general medical condition.
- The child has history of seizures. Except, febrile seizures.
- The child has history of significant head trauma, history of central nervous system tumor.
- The child has history of treatment with clozapine in a dose of ≥ 50 mg/d in the past 2 years.
- The child has history of treatment with Electroconvulsive therapy, Vagus nerve stimulation, transcranial magnetic stimulation in the past 3 months.
Other inclusion and exclusion criteria may apply
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