Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations

Bipolar Disorder Clinical Trial

Official title:

Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01928043
• Other study ID #: 443-2011
• Status: Terminated
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: March 3, 2017

Study information

• Verified date: July 2018
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 3, 2017
• Est. primary completion date: March 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Drug:
• Curcumin

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	The Depressive and Bipolar Disorder Alternative Treatment Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Oxidative Stress Markers	Obtained through blood work	Change from baseline to endpoint (measured at weeks 0, 4, 8)
Primary	Pro-Inflammatory Markers	Obtained through blood work	Change from baseline to endpoint (measured at weeks 0, 4, 8)
Primary	Endothelial Function	Will be assessed via RH-PAT using the EndoPAT	Change from baseline to endpoint (measured at weeks 0, 4, 8)
Secondary	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)
Secondary	KSADS Depression Section (KDRS)	Measures mood symptoms severity	Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Secondary	KSADS Mania Rating Scale (KMRS)	Measures symptoms severity	Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Secondary	Young Mania Rating Scale (YMRS)	Measures symptom severity	Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Secondary	Screen for Child Anxiety Related Emotional Disorders (SCARED)	Anxiety self-report	Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Secondary	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)
Secondary	Blood Pressure		Change from baseline to endpoint (measured at 0, 4, 8)
Secondary	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)