Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Study Overview
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Brief Summary
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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
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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
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Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Lamotrigine


Participation Criteria
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Eligibility Criteria
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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. 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lamotrigine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary measures will include the YMRS, and CGI Bipolar version. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mixed mania, lamotrigine