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 disorder) who use lithium. In the following 50 weeks it is investigated whether these patients experience effect on their depressive and/ or (hypo)manic episodes...
Date First Received: September 21, 2005
Last Updated: June 9, 2008
Verified by: GlaxoSmithKline, June 2008
Clinical Trial Phase: Phase 3 | Start Date: June 2002
Overall Status: Completed
Estimated Enrollment: 120
Brief Summary
Official Title: “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 Depression Followed by Long-Term Prevention of Relapse and Recurrence of Depression and/or Mania in Subjects With Bipolar Disorder”
Condition Keyword(s):
Intervention(s):
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 disorder) who use lithium. In the following 50 weeks it is investigated whether these patients experience effect on their depressive and/ or (hypo)manic episodes.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: lamotrigine
Outcome Measures for this Clinical Trial
Primary Measures
- Score on the MADRS depression rating scale at week 8 compared to baseline
Secondary Measures
- Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on August 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00224510
Study ID Number: SCA30905
ClinicalTrials.gov Identifier: NCT00224510
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Clinical Trials Authorship and Review
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