Lamictal As Add on Treatment in Mixed States of Bipolar Disorder
This study has been completed.
Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00223509
First received: September 13, 2005
Last updated: June 19, 2012
Last verified: June 2012
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Purpose
- 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
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Lamotrigine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Lamictal As Add on Treatment in Mixed States of Bipolar Disorder |
Resource links provided by NLM:
MedlinePlus related topics:
Bipolar Disorder
Drug Information available for:
Lamotrigine
U.S. FDA Resources
Further study details as provided by The University of Texas Health Science Center at San Antonio:
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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- MADRS [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- 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.
| Enrollment: | 28 |
| Study Start Date: | August 2005 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
- 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
Eligibility| Ages Eligible for Study: | 13 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223509
Locations
| United States, Texas | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Univ of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
GlaxoSmithKline
Investigators
| Principal Investigator: | Vivek - Singh, MD | University of Texas |
| Principal Investigator: | Charles L Bowden, MD | University of Texas |
More Information
No publications provided
| Responsible Party: | The University of Texas Health Science Center at San Antonio |
| ClinicalTrials.gov Identifier: | NCT00223509 History of Changes |
| Other Study ID Numbers: | 0340013418 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The University of Texas Health Science Center at San Antonio:
|
mixed mania lamotrigine |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Lamotrigine Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Anticonvulsants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013