Bipolar Depression Before and After Lamotrigine Treatment With Lamictal® (1HMRS-BP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01042496
First received: January 4, 2010
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

This study will compare glutamate and other neurometabolites measured by proton magnetic resonance spectroscopy (1H-MRS) in bipolar I and II patients currently depressed with age-matched healthy controls. The study will also compare 1H-MRS of bipolar I and II patients before and after taking a 12-week course of lamotrigine. This study requires 8 visits over a 12 week period. These visits need to occurs at Mayo Clinic in Rochester, MN.


Condition Intervention Phase
Bipolar Depression
Drug: Lamotrigine 12 week open trial
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 1H-MR Spectroscopy of Bipolar Depression Before and After Lamotrigine Treatment

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Montgomery-Åsberg Depression Rating Scale (MADRS) score [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate, by 1H-MR spectroscopy at 3T, regional specificity [anterior cingulate (AC) vs. dorsolateral prefrontal cortex (DLPFC)] of cerebral metabolites (Glutamate, glutamine, NAA) in bipolar depression before and after Lamotrigine treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: December 2009
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lamotrigine Drug: Lamotrigine 12 week open trial
25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks
Other Name: Lamictal®

Detailed Description:

Depression is the predominant prevailing pole in bipolar disorder and it is associated with substantial morbidity and mortality. However, in comparison to acute mania, bipolar depression is understudied both from the standpoint of its pathophysiology as well as clinical trials and FDA-approved treatments. With little guidance, clinicians and patients are limited as to what evidence-based treatment is available for bipolar depression. Proton magnetic resonance spectroscopy (1H-MRS) is a valuable, non-invasive method to study in-vivo brain biochemistry. Of the novel imaging paradigms, MRS is uniquely positioned to investigate biochemical mechanism of drug action that is objectively measurable and clinically relevant. As there is increasing interest in glutamatergic dysregulation in mood disorders, this project will utilize 1H-MRS at 3T to study glutamate and glutamine levels in brain regions implicated in bipolar disorder [anterior cingulate (Brodmann's areas 24a/b and 32) and dorsolateral prefrontal cortex (Brodmann's 9/46)]. The goal of this project is to evaluate whether anterior cingulate and prefrontal cortex glutamine, quantified as a CSF-corrected absolute concentration percent change from baseline, is associated with clinical remission (MADRS=12) to the anti-glutamatergic mood stabilizer lamotrigine.

This is a 5-year single-site study (RO1 MH079261) of bipolar depression utilizing 1H-MR spectroscopy at 3T before and after treatment with lamotrigine.. At baseline bipolar depressed subjects and age-matched controls will undergo a 1H-MRS on a GE 3T Signa MRI scanner at Mayo Clinic Rochester. The bipolar depressed subjects will then be placed on 12-week, open evaluation of lamotrigine monotherapy. After 12 weeks, the bipolar subjects will undergo a second 1H-MRS scan.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Bipolar Type I or II diagnosis.
  • Currently depressed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042496

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lee J Gunderson       gunderson.lee@mayo.edu   
Principal Investigator: Mark A Frye, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Frye, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Mark Frye, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01042496     History of Changes
Other Study ID Numbers: 09-004163, R01MH079261-01A2
Study First Received: January 4, 2010
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Bipolar
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
Lamotrigine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on September 16, 2014