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A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium

Primary Purpose

Bipolar Disorder, Bipolar Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lamotrigine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder bipolar depression lamotrigine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Score on the MADRS depression rating scale at week 8 compared to baseline

Secondary Outcome Measures

Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline

Full Information

First Posted
September 21, 2005
Last Updated
May 24, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00224510
Brief Title
A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium
Official Title
A Mulitcentre, Double-blind, Randomised, Fixed-dose Evaluation of the Safety and Efficacy of Lamictal (Lamotrigine) Compared to Placebo as an add-on Therapy to Lithium or Another Mood Stabiliser in the Treatment of Bipolar Depression, Followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Patients With Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2002 (Actual)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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 Depression followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Subjects With Bipolar Disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Bipolar Depression
Keywords
bipolar disorder bipolar depression lamotrigine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lamotrigine
Primary Outcome Measure Information:
Title
Score on the MADRS depression rating scale at week 8 compared to baseline
Secondary Outcome Measure Information:
Title
Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amersfoort
ZIP/Postal Code
3818 EW
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1075 GB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Bennebroek
ZIP/Postal Code
2121 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Blaricum
ZIP/Postal Code
1261 AN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Den Haag
ZIP/Postal Code
2553 RJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Dordrecht
ZIP/Postal Code
3317 NM
Country
Netherlands
Facility Name
GSK Investigational Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Enschede
ZIP/Postal Code
7511JX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Gouda
ZIP/Postal Code
2803 RT
Country
Netherlands
Facility Name
GSK Investigational Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Hoorn
ZIP/Postal Code
1624 NP
Country
Netherlands
Facility Name
GSK Investigational Site
City
Leiden
ZIP/Postal Code
2333 ZB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Raalte
ZIP/Postal Code
8102 RR
Country
Netherlands
Facility Name
GSK Investigational Site
City
Retranchement
ZIP/Postal Code
4525 LG
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rosmalen
ZIP/Postal Code
5248 NT
Country
Netherlands
Facility Name
GSK Investigational Site
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3512 PG
Country
Netherlands
Facility Name
GSK Investigational Site
City
Vlissingen
ZIP/Postal Code
4382 EE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Weert
ZIP/Postal Code
6001 BE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Alava
ZIP/Postal Code
01004
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

Citations:
Citation
Poster presented at the APA congress, US, 2007 (Lamotrigine as add-on to lithium in bipolar depression) and the 5th European Stanley Conference on Bipolar Disorder in Barcelona, 2006)
Results Reference
background
PubMed Identifier
19200421
Citation
van der Loos ML, Mulder PG, Hartong EG, Blom MB, Vergouwen AC, de Keyzer HJ, Notten PJ, Luteijn ML, Timmermans MA, Vieta E, Nolen WA; LamLit Study Group. Efficacy and safety of lamotrigine as add-on treatment to lithium in bipolar depression: a multicenter, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 Feb;70(2):223-31. doi: 10.4088/jcp.08m04152. Epub 2008 Dec 30.
Results Reference
background
PubMed Identifier
20136801
Citation
van der Loos ML, Mulder P, Hartong EG, Blom MB, Vergouwen AC, van Noorden MS, Timmermans MA, Vieta E, Nolen WA; LamLit Study Group. Efficacy and safety of two treatment algorithms in bipolar depression consisting of a combination of lithium, lamotrigine or placebo and paroxetine. Acta Psychiatr Scand. 2010 Sep;122(3):246-54. doi: 10.1111/j.1600-0447.2009.01537.x. Epub 2010 Feb 5.
Results Reference
derived

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A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium

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