NCT00214877

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2003

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

First QC Date

September 20, 2005

Last Update Submit

March 28, 2008

Conditions

Bipolar Disorder

Keywords

methylene blue for cognitive dysfunction in bipolar disorder

Outcome Measures

Primary Outcomes (4)

  • Young Mania Rating Scale

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

  • Clinical Global Impression Scale CGI-BP (41)

  • Affective Morbidity Index (42)

Secondary Outcomes (3)

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

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

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

Interventions

Methylene BlueDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CDHA- QE II Health Sciences Centre

Halifax, Nova Scotia, B3H-2E2, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 3K7, Canada

Location

Related Publications (1)

  • 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.

    PMID: 27284082DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Martin Alda, MD FRCPC

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

November 1, 2003

Study Completion

October 1, 2007

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

CA(2)