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

NCT01928043 | Terminated Phase 2 DMC

• 1 other identifier: 443-2011
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (8)

• Clinical Global Impression - Bipolar Disorder Version (CGI BP)

  Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)

• KSADS Depression Section (KDRS)

  Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)

• KSADS Mania Rating Scale (KMRS)

  Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)

• Young Mania Rating Scale (YMRS)

  Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)

• Screen for Child Anxiety Related Emotional Disorders (SCARED)

  Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)

Study Arms (1)

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.

Drug: Curcumin

Interventions

Curcumin DRUG

Also known as: turmeric

adjunctive curcumin

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• The Depressive and Bipolar Disorder Alternative Treatment Foundation: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Benjamin I Goldstein, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, University of Toronto

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 23, 2013
• Study Start: September 1, 2013
• Primary Completion: March 3, 2017
• Study Completion: March 3, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

CA (1)