Bipolar Disorder
Conditions
Keywords
mixed mania, lamotrigine
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
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
Interventions
DRUGLamotrigine
Sponsors
GlaxoSmithKline
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary measures will include the YMRS, and CGI Bipolar version. | — |
Countries
United States
Outcome results
None listed