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

NCT ID: NCT01928043

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-03-03

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

adjunctive curcumin

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.

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Interventions

Curcumin

Intervention Type: DRUG

Other Intervention Names

turmeric

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Depressive and Bipolar Disorder Alternative Treatment Foundation

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Benjamin Goldstein

Associate Professor, University of Toronto

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin I Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

443-2011

Identifier Type: -

Identifier Source: org_study_id