NCT Number: NCT00223509
Lamictal As Add on Treatment in Mixed States of Bipolar Disorder
* 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
Looking for future studies?
Notify MeKey information
Age range
13 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Univ of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
About this study
- 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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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
Time frame: 12 weeks
-
MADRS
Time frame: 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 outcomes
-
Secondary measures will include the YMRS, and CGI Bipolar version.
Sponsors and collaborators
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Collaborators
- GlaxoSmithKline
Registry information
Important dates
- Study start
- 2005
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Sep 22, 2005
- Registry last updated
- Jun 20, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
NCT02481245
Bipolar Disorder, Bipolar and Related Disorders
Boston, Massachusetts, United States
View Trial DetailsLithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder
NCT03336918
Behavior, Behavioral Symptoms
Cleveland, Ohio, United States
View Trial DetailsEffects of Theta Burst Stimulation on the Brain, Behavior, and Clinical Symptoms in Adults With Bipolar Disorder
NCT04696471
Bipolar Disorder, Bipolar and Related Disorders
Pittsburgh, Pennsylvania, United States
View Trial DetailsBetter Sleep in Psychiatric Care - Bipolar
NCT04130529
Bipolar Disorder, Bipolar and Related Disorders
Stockholm, Stockholm County, Sweden
View Trial Details