Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

NCT00223509 | Completed Phase 4 DMC

• 1 other identifier: 0340013418
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

• To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder.
• To evaluate the efficacy and of a combination of LAM+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder

Conditions

Bipolar Disorder

Keywords

mixed mania; lamotrigine

Outcome Measures

Primary Outcomes (4)

• Primary efficacy, during the first 10 weeks (acute phase) of the study, will be assessed by the proportion of patients achieving a 50% reduction of their depressive symptoms as assessed by the MADRS and a GAF

  12 weeks

• MADRS

  12 weeks

• Efficacy, during the maintenance phase of the study, will be assessed by the proportion of patients able to maintain a response, at the end of the study, as defined by

• MADRS total score of <14, GAF score 51. Secondary measures will include the YMRS, and CGI Bipolar version.

Secondary Outcomes (1)

• Secondary measures will include the YMRS, and CGI Bipolar version.

Interventions

Lamotrigine DRUG

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be included in the study patient must meet criteria A, C, D, E, F, G plus any 1 of the 3 criteria listed in section B.
• A. Patients meeting DSM-IV diagnosis of bipolar disorder, I or II
• Patients meeting DSM-IV diagnostic criteria for a manic/hypomanic episode with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or
• Patients meeting DSM-IV symptomatic criteria for a hypomanic/manic episode for a period of 2 days or longer, with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or
• Patients meeting DSM-IV criteria for a depressive episode associated with at least three DSM-IV manic/hypomanic symptoms
• C.MADRS of ≥14
• D.YMRS of ≥ 14
• E. Age 13years to 75 years
• F. Male or female
• G. Outpatient

You may not qualify if:

• illness precluding the use of LAM
• Alcohol/drug dependence in the past one month
• patients with a history of a rash on LAM
• CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
• history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma
• patients currently taking LAM

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

Univ of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Vivek - Singh, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Charles L Bowden, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

US (2)