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

July 20, 2018 updated by: Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Curcumin
Other Names:
  • turmeric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Depression Rating Scale - Revise (CDRS-R)
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
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
Time Frame: Change from baseline to endpoint (measured at weeks 0, 4, 8)
Obtained through blood work
Change from baseline to endpoint (measured at weeks 0, 4, 8)
Pro-Inflammatory Markers
Time Frame: Change from baseline to endpoint (measured at weeks 0, 4, 8)
Obtained through blood work
Change from baseline to endpoint (measured at weeks 0, 4, 8)
Endothelial Function
Time Frame: Change from baseline to endpoint (measured at weeks 0, 4, 8)
Will be assessed via RH-PAT using the EndoPAT
Change from baseline to endpoint (measured at weeks 0, 4, 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression - Bipolar Disorder Version (CGI BP)
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
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)
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Measures mood symptoms severity
Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
KSADS Mania Rating Scale (KMRS)
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Measures symptoms severity
Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Young Mania Rating Scale (YMRS)
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Measures symptom severity
Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Anxiety self-report
Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Weight Gain
Time Frame: Change from baseline to endpoint (measured at 0, 4, 8)
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
Time Frame: Change from baseline to endpoint (measured at 0, 4, 8)
Change from baseline to endpoint (measured at 0, 4, 8)
Side Effects for Children and Adolescents (SEFCA)
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 4, 6, 8)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

The Depressive and Bipolar Disorder Alternative Treatment Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

March 3, 2017

Study Completion (ACTUAL)

March 3, 2017

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (ESTIMATE)

August 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 20, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 443-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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