Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Completed · Phase 4

Conditions studied: Bipolar Disorder

In brief

* 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

Key facts

Study ID

NCT00223509

Run by

The University of Texas Health Science Center at San Antonio

People needed

28

Starts

2005-08-01

Expected to finish

2007-11-01

Last updated by the study team

2012-06-20

Who can join

Age: 13 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Univ of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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