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

Primary Purpose

Bipolar Disorder

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Curcumin
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adjunctive curcumin

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Oxidative Stress Markers
Obtained through blood work
Pro-Inflammatory Markers
Obtained through blood work
Endothelial Function
Will be assessed via RH-PAT using the EndoPAT

Secondary Outcome Measures

Clinical Global Impression - Bipolar Disorder Version (CGI BP)
Measures overall illness severity. Remission is defined as an improvement score of 1 or 2.
KSADS Depression Section (KDRS)
Measures mood symptoms severity
KSADS Mania Rating Scale (KMRS)
Measures symptoms severity
Young Mania Rating Scale (YMRS)
Measures symptom severity
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Anxiety self-report
Weight Gain
Significant weight gain is greater than or equal to 7% of baseline weight
Blood Pressure
Side Effects for Children and Adolescents (SEFCA)
SEFCA is a questionnaire that assesses side effects. We anticipate that no major side-effects will have a prevalence of greater than 20%.

Full Information

First Posted
August 20, 2013
Last Updated
July 20, 2018
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
The Depressive and Bipolar Disorder Alternative Treatment Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01928043
Brief Title
Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations
Official Title
Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitment
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 3, 2017 (Actual)
Study Completion Date
March 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
The Depressive and Bipolar Disorder Alternative Treatment Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adjunctive curcumin
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Curcumin
Other Intervention Name(s)
turmeric
Primary Outcome Measure Information:
Title
Children's Depression Rating Scale - Revise (CDRS-R)
Description
Measures mood symptom severity. Response is defined as greater than or equal to 50% reduction in CDRS-R score.
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Title
Oxidative Stress Markers
Description
Obtained through blood work
Time Frame
Change from baseline to endpoint (measured at weeks 0, 4, 8)
Title
Pro-Inflammatory Markers
Description
Obtained through blood work
Time Frame
Change from baseline to endpoint (measured at weeks 0, 4, 8)
Title
Endothelial Function
Description
Will be assessed via RH-PAT using the EndoPAT
Time Frame
Change from baseline to endpoint (measured at weeks 0, 4, 8)
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Bipolar Disorder Version (CGI BP)
Description
Measures overall illness severity. Remission is defined as an improvement score of 1 or 2.
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Title
KSADS Depression Section (KDRS)
Description
Measures mood symptoms severity
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Title
KSADS Mania Rating Scale (KMRS)
Description
Measures symptoms severity
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Title
Young Mania Rating Scale (YMRS)
Description
Measures symptom severity
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Title
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Description
Anxiety self-report
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Title
Weight Gain
Description
Significant weight gain is greater than or equal to 7% of baseline weight
Time Frame
Change from baseline to endpoint (measured at 0, 4, 8)
Title
Blood Pressure
Time Frame
Change from baseline to endpoint (measured at 0, 4, 8)
Title
Side Effects for Children and Adolescents (SEFCA)
Description
SEFCA is a questionnaire that assesses side effects. We anticipate that no major side-effects will have a prevalence of greater than 20%.
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 4, 6, 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin I Goldstein, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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

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