This study will enroll 30 adolescents with bipolar disorder (BD) who are suffering from symptoms of depression despite already taking a traditional mood-stabilizing medication. Curcumin will be added to their current medications for 8 weeks. During these 8 weeks, their mood symptoms will be assessed regularly. Height, weight, and blood pressure will also be measured repeatedly. Blood tests will be completed before treatment, after 4 weeks of treatment, and at the end of the study. Blood tests will allow us to determine whether changes in inflammation and oxidative stress explain curcumin's effect on mood. Finally, we will use sophisticated technology to measure blood vessel functioning. We have three main predictions: 1. Curcumin will improve mood symptoms without causing physical problems; 2. Curcumin will reduce inflammation and oxidative stress, and these reductions will be linked to improvements in mood; 3. Curcumin will improve blood vessel functioning, and these improvements will be linked to improved inflammation and oxidative stress.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Children's Depression Rating Scale - Revise (CDRS-R)
Measures mood symptom severity. Response is defined as greater than or equal to 50% reduction in CDRS-R score.
Time frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Oxidative Stress Markers
Obtained through blood work
Time frame: Change from baseline to endpoint (measured at weeks 0, 4, 8)
Pro-Inflammatory Markers
Obtained through blood work
Time frame: Change from baseline to endpoint (measured at weeks 0, 4, 8)
Endothelial Function
Will be assessed via RH-PAT using the EndoPAT
Time frame: Change from baseline to endpoint (measured at weeks 0, 4, 8)
Clinical Global Impression - Bipolar Disorder Version (CGI BP)
Measures overall illness severity. Remission is defined as an improvement score of 1 or 2.
Time frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
KSADS Depression Section (KDRS)
Measures mood symptoms severity
Time frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
KSADS Mania Rating Scale (KMRS)
Measures symptoms severity
Time frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Young Mania Rating Scale (YMRS)
Measures symptom severity
Time frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Anxiety self-report
Time frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Weight Gain
Significant weight gain is greater than or equal to 7% of baseline weight
Time frame: Change from baseline to endpoint (measured at 0, 4, 8)
Blood Pressure
Time frame: Change from baseline to endpoint (measured at 0, 4, 8)
Side Effects for Children and Adolescents (SEFCA)
SEFCA is a questionnaire that assesses side effects. We anticipate that no major side-effects will have a prevalence of greater than 20%.
Time frame: Change from baseline to endpoint (assessed at weeks 0, 4, 6, 8)
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