Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Condition(s) targeted: Bipolar Disorder

Intervention: Lamotrigine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: The University of Texas Health Science Center at San Antonio

Official(s) and/or principal investigator(s):
Vivek - Singh, MD, Principal Investigator, Affiliation: UTHSCSA
Charles L Bowden, MD, Principal Investigator, Affiliation: UTHSCSA

Overall contact:
Martha - Dahl, R.N., Phone: 210-567-5501, Email: dahlml@uthscsa.edu

- 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

Official title: Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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.

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

Detailed description: 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

Minimum age: 13 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Martha - Dahl, R.N., Phone: 210-567-5501, Email: dahlml@uthscsa.edu

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States; Recruiting
Martha _ Dahl, RN, Phone: 210-567-5501, Email: dahlml@uthscsa.edu

Univ of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States; Recruiting
martha - dahl

Starting date: August 2005
Ending date: October 2010
Last updated: April 24, 2007