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insufficient recruitment
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| Name | Class |
|---|---|
| The Depressive and Bipolar Disorder Alternative Treatment Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adjunctive curcumin | Experimental | Curcumin will be added to their current medications for 8 weeks. Starting dose will be 500mg daily, increased to 500mg twice daily in week 2, then increased to 1000mg twice daily during weeks 3-8. A slower titration will be used for subjects who demonstrate tolerability problems. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) |
| Oxidative Stress Markers | Obtained through blood work | Change from baseline to endpoint (measured at weeks 0, 4, 8) |
| Pro-Inflammatory Markers | Obtained through blood work | Change from baseline to endpoint (measured at weeks 0, 4, 8) |
| Endothelial Function | Will be assessed via RH-PAT using the EndoPAT | Change from baseline to endpoint (measured at weeks 0, 4, 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Bipolar Disorder Version (CGI BP) | Measures overall illness severity. Remission is defined as an improvement score of 1 or 2. | Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) |
| KSADS Depression Section (KDRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin I Goldstein, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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Measures mood symptoms severity |
| Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) |
| KSADS Mania Rating Scale (KMRS) | Measures symptoms severity | Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) |
| Young Mania Rating Scale (YMRS) | Measures symptom severity | Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) |
| Screen for Child Anxiety Related Emotional Disorders (SCARED) | Anxiety self-report | 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 | Change from baseline to endpoint (measured at 0, 4, 8) |
| Blood Pressure | 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%. | Change from baseline to endpoint (assessed at weeks 0, 4, 6, 8) |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |