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Lamictal As Add on Treatment in Mixed States of Bipolar Disorder
This study is currently recruiting participants.
Study NCT00223509   Information provided by The University of Texas Health Science Center at San Antonio
First Received: September 13, 2005   Last Updated: April 24, 2007   History of Changes

September 13, 2005
April 24, 2007
August 2005
 
  • 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
  • MADRS minus 14, GAF score 51. Secondary measures will include the YMRS, and CGI Bipolar version.
  • 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.
Same as current
Complete list of historical versions of study NCT00223509 on ClinicalTrials.gov Archive Site
Secondary measures will include the YMRS, and CGI Bipolar version.
Same as current
 
Lamictal As Add on Treatment in Mixed States of Bipolar Disorder
Lamictal As Add on Treatment in Mixed States of Bipolar Disorder
  • 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
  1. 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.
  2. 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
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Bipolar Disorder
Drug: Lamotrigine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
50
October 2010
 

Inclusion Criteria:

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

B.

  1. 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
  2. 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
  3. 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

Exclusion Criteria:

  1. illness precluding the use of LAM
  2. Alcohol/drug dependence in the past one month
  3. patients with a history of a rash on LAM
  4. CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
  5. 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
  6. patients currently taking LAM
Both
13 Years to 75 Years
No
Contact: Martha - Dahl, R.N. 210-567-5501 dahlml@uthscsa.edu
Contact: Vivek - Singh, MD 210-567-5479 singhv@uthscsa.edu
United States
 
NCT00223509
 
0340013418
The University of Texas Health Science Center at San Antonio
GlaxoSmithKline
Principal Investigator: Vivek - Singh, MD UTHSCSA
Principal Investigator: Charles L Bowden, MD UTHSCSA
The University of Texas Health Science Center at San Antonio
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP