Status:
COMPLETED
A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium
Lead Sponsor:
GlaxoSmithKline
Conditions:
Bipolar Disorder
Bipolar Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a study that, in the first 16 weeks, investigates whether lamotrigine versus placebo offers effect on depressive episodes for patients with bipolar disorder (also known as manic depressive dis...
Detailed Description
A Multicentre, Double-Blind, Randomised, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine (Lamictal®) compared to placebo as add-on therapy to lithium in the Treatment of Bipolar Depres...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with bipolar disorder (type I or type II) currently suffering from depression that is at least moderate in severity according to a psychiatrist.
- Currently using lithium.
- Female subjects can't be pregnant or become pregnant during the study.
- Exclusion criteria:
- Actively suicidal.
- Rapid cyclers.
- Suffering from significant personality disorders.
- Alcohol or substance dependent or abusive.
- Suffering from significant physical conditions.
Exclusion
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00224510
Start Date
August 1 2002
End Date
September 1 2006
Last Update
May 30 2017
Active Locations (31)
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1
GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
2
GSK Investigational Site
Almelo, Netherlands, 7609 PP
3
GSK Investigational Site
Amersfoort, Netherlands, 3818 EW
4
GSK Investigational Site
Amsterdam, Netherlands, 1061 AE