Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223509
• Other study ID #: 0340013418
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: June 19, 2012
• Start date: August 2005
• Est. completion date: November 2007

Study information

• Verified date: June 2012
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Lamotrigine

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	MADRS		12 weeks	Yes
Primary	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
Primary	MADRS total score of <14, GAF score 51. Secondary measures will include the YMRS, and CGI Bipolar version.
Secondary	Secondary measures will include the YMRS, and CGI Bipolar version.