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

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ClinicalTrials.gov Identifier: NCT01928043
Recruitment Status : Terminated (insufficient recruitment)
First Posted : August 23, 2013
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Information provided by (Responsible Party):
Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE August 20, 2013
First Posted Date  ICMJE August 23, 2013
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE September 2013
Actual Primary Completion Date March 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
  • 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.
  • Oxidative Stress Markers [ Time Frame: Change from baseline to endpoint (measured at weeks 0, 4, 8) ]
    Obtained through blood work
  • Pro-Inflammatory Markers [ Time Frame: Change from baseline to endpoint (measured at weeks 0, 4, 8) ]
    Obtained through blood work
  • Endothelial Function [ Time Frame: Change from baseline to endpoint (measured at weeks 0, 4, 8) ]
    Will be assessed via RH-PAT using the EndoPAT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
  • 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.
  • KSADS Depression Section (KDRS) [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) ]
    Measures mood symptoms severity
  • KSADS Mania Rating Scale (KMRS) [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) ]
    Measures symptoms severity
  • Young Mania Rating Scale (YMRS) [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) ]
    Measures symptom severity
  • 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
  • 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
  • Blood Pressure [ Time Frame: 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%.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations
Official Title  ICMJE Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE Drug: Curcumin
Other Name: turmeric
Study Arms  ICMJE 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.
Intervention: Drug: Curcumin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 20, 2018)
7
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2013)
30
Actual Study Completion Date  ICMJE March 3, 2017
Actual Primary Completion Date March 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01928043
Other Study ID Numbers  ICMJE 443-2011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE The Depressive and Bipolar Disorder Alternative Treatment Foundation
Investigators  ICMJE
Principal Investigator: Benjamin I Goldstein, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP