Status:
COMPLETED
Lamictal As Add on Treatment in Mixed States of Bipolar Disorder
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Bipolar Disorder
Eligibility:
All Genders
13-75 years
Phase:
PHASE4
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 combinatio...
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 combinat...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00223509
Start Date
August 1 2005
End Date
November 1 2007
Last Update
June 20 2012
Active Locations (2)
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1
Univ of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
2
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229