Bipolar DisorderPhase 2NCT01928043
Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations
A Phase 2 study testing Curcumin in people with Bipolar Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Curcumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to 3 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Curcumin
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called turmeric
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Oxidative Stress Markers
Obtained through blood work
Measured: Change from baseline to endpoint (measured at weeks 0, 4, 8)
Pro-Inflammatory Markers
Obtained through blood work
Measured: Change from baseline to endpoint (measured at weeks 0, 4, 8)
Endothelial Function
Will be assessed via RH-PAT using the EndoPAT
Measured: Change from baseline to endpoint (measured at weeks 0, 4, 8)
Secondary outcomes (8)
Clinical Global Impression - Bipolar Disorder Version (CGI BP)
Measures overall illness severity. Remission is defined as an improvement score of 1 or 2.
Measured: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
KSADS Depression Section (KDRS)
Measures mood symptoms severity
Measured: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
KSADS Mania Rating Scale (KMRS)
Measures symptoms severity
Measured: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Young Mania Rating Scale (YMRS)
Measures symptom severity
Measured: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Anxiety self-report
Measured: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)
Weight Gain
Significant weight gain is greater than or equal to 7% of baseline weight
Measured: Change from baseline to endpoint (measured at 0, 4, 8)
Blood Pressure
Measured: Change from baseline to endpoint (measured at 0, 4, 8)
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%.
Measured: Change from baseline to endpoint (assessed at weeks 0, 4, 6, 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startSep 2013
- Primary completion3 Mar 2017
- Study completion3 Mar 2017
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- The Depressive and Bipolar Disorder Alternative Treatment Foundation
- Responsible party
- Principal investigator, Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre
- Investigators
- Benjamin I Goldstein, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928043
- Sponsor's protocol ID
- 443-2011
- Status last verified
- Jul 2018
- First submitted
- 20 Aug 2013
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations
- ClinicalTrials.gov ID
- NCT01928043
- Acronym / sponsor ID
- 443-2011
- Conditions
- Bipolar Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- The Depressive and Bipolar Disorder Alternative Treatment Foundation
- Study start
- Sep 2013
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adjunctive curcumin | Experimental | Drug: CurcuminCurcumin 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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: turmeric | Drug | adjunctive curcumin |
Primary outcome
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
8 secondary outcomes
Clinical Global Impression - Bipolar Disorder Version (CGI BP)
Time frame: 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)
KSADS Mania Rating Scale (KMRS)
Time frame: 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)
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: 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)
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)
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin I Goldstein, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin in people with Bipolar Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Depression Rating Scale - Revise (CDRS-R) (time frame: Change from baseline to endpoint (assessed at weeks 0, 2, 4, 6, 8)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.