Clinical trial NCT01928043: Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations
Official title: Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bipolar Disorder
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: The Depressive and Bipolar Disorder Alternative Treatment Foundation
First posted: 2013-08-23
Enrollment: 7
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* English speaking
* all races and ethnicities
* bipolar disorder I or II
* currently treated with lithium, divalproex, lamotrigine, and/or second generation antipsychotic
* doses stable for greater than or equal to 4 weeks
* current CGI BP score of moderate or greater
* current CDRS-R severity of greater than or equal to 35

Exclusion Criteria:

* If female, pregnant or sexually active without reliable contraception
* significant suicidal ideations (as determined by clinical interview or CDRS-R \> 3) and/or any suicidal intent, even if fleeting or non-recurrent, in the preceding 2 weeks
* substance dependence within the past 2 months
* daily antidepressant, glucocorticoid, nonsteroidal anti-inflammatory, anti-platelet, anti-coagulant, antacid, or oral hypoglycemic medication or insulin; high-dose antioxidant vitamin supplements or other natural health products that may function as an antidepressant within 30 days of baseline
* IQ\<80 or autistic disorder
* full threshold mania and/or YMRS \> 20 and/or psychosis
* hypersensitivity to curcumin/turmeric, gelatin
* dietary consumption of curcumin/turmeric \> 3 times/week
* clinically significant or unstable medical disorder; known gallstones and/or bile duct obstruction, stomach ulcers, excessive stomach acid/heartburn/gastroesophageal reflux disease (GERD); or clinically significant baseline laboratory abnormalities; or ALT and /or AST above the upper limit of normal on repeat examination at baseline
* severe depression (CDRS-R \> 98) and/or severely ill (CGI BP \>5)

Primary outcomes:
measure: Children's Depression Rating Scale - Revise (CDRS-R)
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
measure: Oxidative Stress Markers
timeFrame: Change from baseline to endpoint (measured at weeks 0, 4, 8)
measure: Pro-Inflammatory Markers
timeFrame: Change from baseline to endpoint (measured at weeks 0, 4, 8)
measure: Endothelial Function
timeFrame: Change from baseline to endpoint (measured at weeks 0, 4, 8)
Secondary outcomes:
measure: Clinical Global Impression - Bipolar Disorder Version (CGI BP)
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
measure: KSADS Depression Section (KDRS)
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
measure: KSADS Mania Rating Scale (KMRS)
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
measure: Young Mania Rating Scale (YMRS)
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
measure: Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
measure: Weight Gain
timeFrame: Change from baseline to endpoint (measured at 0, 4, 8)
measure: Blood Pressure
timeFrame: Change from baseline to endpoint (measured at 0, 4, 8)
measure: Side Effects for Children and Adolescents (SEFCA)
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 4, 6, 8)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Benjamin I Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References: