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Bipolar DisorderPhase 3NCT00214877

Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

A Phase 3 study testing Methylene Blue in people with Bipolar Disorder, run by Nova Scotia Health Authority at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder
What is being tested?
Methylene Blue
How many people
40 participants
Where
2 sitesCanada
Study dates
Nov 2003to Oct 2007
Phase
Phase 3
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women between the ages of 18 and 65 who meet both RDC and DSM-IV criteria for bipolar I or bipolar II disorder will be recruited.
  • All subjects will be interviewed using SADS interview (40) with added questions as to arrive at DSM-IV diagnoses as well.
  • The patients will be treated with lamotrigine as their main mood stabilizer. Patients recruited for the study will show at least partial response to prophylactic treatment with respect to the mood symptoms.
  • HAM-D (17 item) scores at study entry will be 15 or lower and Y MRS scores will be less than 15.

Who cannot join

  • Patients not able to give informed consent
  • Patients with active substance abuse or dependence or a history of such within the past two years
  • Physical illness, mainly liver and kidney disorders and G-6-PD deficiency
  • Subjects previously treated with methylene blue
  • Pregnant or breast-feeding women
  • Subjects who have had ECT within the past two years
  • Patients with known brain injury or loss of consciousness of duration greater than ten minutes
  • Subjects taking concurrent medications that are known to have cognitive effects (eg. beta blockers)

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • CDHA- QE II Health Sciences Centre

    Halifax, Nova Scotia, B3H-2E2

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 3K7

Other trials in Canada

About this study

Official title: Double-Blind Trial of Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine.

Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.

Read the detailed description

This is a double blind cross-over study. There are two dose ranges in this study. A cross over design means that some patients will start at one dose range and others with another. About half way through the study, patients will then be switched over to the other dose range. Patients partially stabilized on lamotrigine will be randomized to either subtherapeutic (16mg) or therapeutic (200mg) dose of methylene blue. This design is necessary because methylene blue stains urine and thus it is not possible to use a traditional placebo. Double-blind means that neither the doctor nor the patient will know which strength of study drug the patient will be on at what point in the study. The study will be conducted in three centres, each recruiting 20 subjects over a two-year period. The duration of the study is 6 months.

Being tested
Methylene Blue
Keywords
methylene blue for cognitive dysfunction in bipolar disorder
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methylene BlueDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Young Mania Rating Scale

  2. Hamilton Depression Rating Scale (HAM-D), 17-item version Hamilton Rating Scale for Anxiety (HAM-A).

  3. Clinical Global Impression Scale CGI-BP (41)

  4. Affective Morbidity Index (42)

Secondary outcomes (3)

  1. California Verbal Learning Task and a process dissociation task. Two tasks will focus on selective attention, negative priming and inhibition of return tasks.

  2. A visual backward masking task that has been well studied in patients with BD will be used.

  3. Trails B will be administered as a test of executive function.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startNov 2003
  3. Study completionOct 2007

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00214877
Sponsor's protocol ID
QE-RS/2002-173
Other IDs
Stanley Foundation # 02T-166
Status last verified
Mar 2008
First submitted
20 Sep 2005
Last updated
1 Apr 2008
Results posted
No
Data monitoring committee
No

Publications

  • Alda M, McKinnon M, Blagdon R, Garnham J, MacLellan S, O'Donovan C, Hajek T, Nair C, Dursun S, MacQueen G. Methylene blue treatment for residual symptoms of bipolar disorder: randomised crossover study. Br J Psychiatry. 2017 Jan;210(1):54-60. doi: 10.1192/bjp.bp.115.173930. Epub 2016 Jun 9.

    PubMed 27284082

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methylene Blue in people with Bipolar Disorder, run by Nova Scotia Health Authority at 2 sites 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Young Mania Rating Scale. 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?

On the ClinicalTrials.gov record for NCT00214877, which also lists 1 linked publication.

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 1 Apr 2008.

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