Status:
COMPLETED
Omega-3 and Therapy Study for Childhood Bipolar Disorder- Not Otherwise Specified
Lead Sponsor:
L. Eugene Arnold
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Eligibility:
All Genders
7-14 years
Phase:
PHASE1
Brief Summary
Childhood bipolar disorder- not otherwise specified (BP-NOS) was originally considered to be a milder version of bipolar disorder (BD). Research now indicates that BP-NOS is a highly impairing conditi...
Detailed Description
Research indicates BP-NOS is a highly impairing condition comparable to the other bipolar spectrum disorders. Considerable gains have been made recently in understanding BP-NOS, in large part by resea...
Eligibility Criteria
Inclusion
- Aged 7-14 years (boys and girls)
- Has a diagnosis of BP-NOS according to the LAMS definition. Criteria as follows:
- Clinically significant bipolar symptoms that do not meet DSM IV TR criteria for bipolar disorder I or bipolar disorder II
- Elated mood plus 2 or more associated symptoms from DSM IV TR or irritable mood plus 3 or more symptoms
- A change in functioning, and a minimum duration of 4 hours within a 24-hour period and at least 4 cumulative lifetime days meeting criteria
- Full scale IQ ≥ 70
- Child and one parent or other caregiver must be able to complete all assessment
- Child must be able to swallow capsules (training in swallowing will be offered)
- Parent and child must be willing to have blood drawn from child at two study assessments.
Exclusion
- Major medical disorders (eg diabetes, epilepsy, metabolic disorder)
- Inability to communicate in English
- Lack of access via phone
- Autism
- Schizophrenia, or other psychotic states warranting anti-psychotic medication
- Active suicidal concern (e.g., "I want to kill myself", a plan for suicide, or an attempt in the past month; however, passive suicidal ideation, such as "I wish I were dead" would not exclude)
- Three or more symptoms rated as "marked" or "severe" on the KDRS or KMRS
- Concurrent mental health intervention (pharmacotherapy and/or psychotherapy) in the past month.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01507753
Start Date
September 1 2011
End Date
September 1 2014
Last Update
March 8 2016
Active Locations (1)
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1
Ohio State University Medical Center- Harding Hospital
Columbus, Ohio, United States, 43210