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Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lamotrigine
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring mixed mania, lamotrigine

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univ of Texas Health Science Center at San Antonio
  • University of Texas Health Science Center at San Antonio

Outcomes

Primary Outcome Measures

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
MADRS
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

Secondary measures will include the YMRS, and CGI Bipolar version.

Full Information

First Posted
September 13, 2005
Last Updated
June 19, 2012
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00223509
Brief Title
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
mixed mania, lamotrigine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Primary Outcome Measure Information:
Title
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
Title
MADRS
Time Frame
12 weeks
Title
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
Title
MADRS total score of <14, GAF score 51. Secondary measures will include the YMRS, and CGI Bipolar version.
Secondary Outcome Measure Information:
Title
Secondary measures will include the YMRS, and CGI Bipolar version.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek - Singh, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles L Bowden, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

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