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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Curcumin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations
Study Start Date : September 2013
Actual Primary Completion Date : March 3, 2017
Actual Study Completion Date : March 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Curcumin

Arms and Interventions
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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 Name: turmeric


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Oxidative Stress Markers [ Time Frame: Change from baseline to endpoint (measured at weeks 0, 4, 8) ]
    Obtained through blood work

  3. Pro-Inflammatory Markers [ Time Frame: Change from baseline to endpoint (measured at weeks 0, 4, 8) ]
    Obtained through blood work

  4. Endothelial Function [ Time Frame: Change from baseline to endpoint (measured at weeks 0, 4, 8) ]
    Will be assessed via RH-PAT using the EndoPAT


Secondary Outcome Measures :
  1. 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.

  2. KSADS Depression Section (KDRS) [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) ]
    Measures mood symptoms severity

  3. KSADS Mania Rating Scale (KMRS) [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) ]
    Measures symptoms severity

  4. Young Mania Rating Scale (YMRS) [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8) ]
    Measures symptom severity

  5. 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

  6. 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

  7. Blood Pressure [ Time Frame: Change from baseline to endpoint (measured at 0, 4, 8) ]
  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%.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928043


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Investigators
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Principal Investigator: Benjamin I Goldstein, MD Sunnybrook Health Sciences Centre
More Information
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Responsible Party: Dr. Benjamin Goldstein, Associate Professor, University of Toronto, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01928043    
Other Study ID Numbers: 443-2011
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action