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Trial · Interventional

CompletedPhase 3Registry data

Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

NCTNCT00214877 (opens ClinicalTrials.gov in a new tab)Other idQE-RS/2002-173Other idStanley Foundation # 02T-166
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
40 participants (estimated)
Sponsor
Nova Scotia Health Authority · Other
Design
Randomized · Double masking
Countries
1 country

Canada

Start
Nov 2003
Primary completion
Not stated
Completion
Oct 2007
First posted
22 Sept 2005 (estimated)
Last update posted
1 Apr 2008 (estimated)
Conditions
Bipolar Disorder

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200320042005200620072008
  1. Ph 3

    Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

    NCT00214877

    Nov 2003 to Oct 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Methylene BlueDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes4

Outcomes the sponsor listed as primary.

  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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

6 results

Methylene blue treatment for residual symptoms of bipolar disorder: randomised crossover study.

Alda et al. 2017The British journal of psychiatry : the journal of mental sciencecited by 44

PMID 27284082DOI 10.1192/bjp.bp.115.173930PUB-27284082

Rights unknown6 results
Source linkSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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)

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