NCT00206778

Brief Summary

We are comparing the efficacy of Lamotrigine to that of Standard of Care Sodium Valproate for the treatment of Mixed Mania. The study hypothesis is that Lamotrigine will be more efficative for treating mixed mania in patients with Bipolar Disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

November 25, 2010

Status Verified

November 1, 2010

Enrollment Period

4 years

First QC Date

September 16, 2005

Last Update Submit

November 24, 2010

Conditions

Mixed Mania Bipolar Disorder

Keywords

Mixed maniaBipolar Disorder

Interventions

LamotrigineDRUG
Sodium ValproateDRUG

Eligibility Criteria

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

You may qualify if:

  • Males and females, ages 18-65.
  • Ability to sign an informed consent
  • Diagnosis of Bipolar Mood Disorder I, manic episode.
  • Mania Rating Scale (MRS) score of at least 11
  • HDRS score of at least 18
  • Global Assessment Scale (GAS) scores more than 60.

You may not qualify if:

  • Alcohol or substance abuse within the last 6 months
  • Current diagnosis of Obsessive-Compulsive Disorder
  • Current diagnosis of Schizophrenia or Schizoaffective Disorder
  • Previous adverse reaction or allergies to lamotrigine or sodium valproate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

LamotrigineValproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TriazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Igor Galynker, MD, PhD

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 21, 2005

Study Start

July 1, 2003

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

November 25, 2010

Record last verified: 2010-11

Locations

US(1)