Clinical trial NCT00223509: Lamictal As Add on Treatment in Mixed States of Bipolar Disorder
Official title: Lamictal As Add on Treatment in Mixed States of Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: mixed mania
lamotrigine
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-22
Enrollment: 28
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 weeks
measure: MADRS
timeFrame: 12 weeks
measure: 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
measure: MADRS total score of <14, GAF score 51. Secondary measures will include the YMRS, and CGI Bipolar version.
Secondary outcomes:
measure: Secondary measures will include the YMRS, and CGI Bipolar version.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Univ of Texas Health Science Center at San Antonio
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas
name: Vivek - Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Charles L Bowden, MD
role: PRINCIPAL_INVESTIGATOR
References: