Bipolar DisorderPhase 3NCT00224510
A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium
A Phase 3 study testing lamotrigine in people with Bipolar Disorder and Bipolar Depression, run by GlaxoSmithKline at 31 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression
- What is being tested?
- lamotrigine
- How many people
- 120 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Aug 2002to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Actively suicidal.
- Rapid cyclers.
- Suffering from significant personality disorders.
- Alcohol or substance dependent or abusive.
- Suffering from significant physical conditions.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
Netherlands25 sites
GSK Investigational Site
Alkmaar, 1815 JD
GSK Investigational Site
Almelo, 7609 PP
GSK Investigational Site
Amersfoort, 3818 EW
GSK Investigational Site
Amsterdam, 1061 AE
GSK Investigational Site
Amsterdam, 1075 GB
GSK Investigational Site
Bennebroek, 2121 AD
GSK Investigational Site
Blaricum, 1261 AN
GSK Investigational Site
Delft, 2625 AD
GSK Investigational Site
Dordrecht, 3317 NM
GSK Investigational Site
Eindhoven, 5623 EJ
GSK Investigational Site
Enschede, 7511JX
GSK Investigational Site
Flushing, 4382 EE
GSK Investigational Site
Gouda, 2803 RT
GSK Investigational Site
Groningen, 9713 GZ
GSK Investigational Site
Hoorn, 1624 NP
GSK Investigational Site
Leiden, 2333 ZB
GSK Investigational Site
Nijmegen, 6532 SZ
GSK Investigational Site
Raalte, 8102 RR
GSK Investigational Site
Retranchement, 4525 LG
GSK Investigational Site
Rosmalen, 5248 NT
GSK Investigational Site
The Hague, 2553 RJ
GSK Investigational Site
Tilburg, 5022 GC
GSK Investigational Site
Utrecht, 3512 PG
GSK Investigational Site
Weert, 6001 BE
GSK Investigational Site
Zwolle, 8025 AB
Spain6 sites
GSK Investigational Site
Alava, 01004
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Madrid, 28035
GSK Investigational Site
Valencia, 46009
About this study
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
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.
Read the 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
- Conditions
- Bipolar Disorder, Bipolar Depression
- Being tested
- lamotrigine
- Keywords
- bipolar disorder bipolar depression lamotrigine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamotrigineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the MADRS depression rating scale at week 8 compared to baseline
Secondary outcomes (1)
Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224510
- Sponsor's protocol ID
- SCA30905
- Status last verified
- May 2017
- First submitted
- 21 Sep 2005
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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)
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.
PubMed 19200421van 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.
PubMed 20136801
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00224510
- Acronym / sponsor ID
- SCA30905
- Conditions
- Bipolar Disorder, Bipolar Depression
- Keywords
- bipolar disorder bipolar depression lamotrigine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2002 (actual)
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Actively suicidal.
- Rapid cyclers.
- Suffering from significant personality disorders.
- Alcohol or substance dependent or abusive.
- Suffering from significant physical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lamotrigine | Drug | – |
Primary outcome
Score on the MADRS depression rating scale at week 8 compared to baseline
1 secondary outcome
Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- BackgroundPoster 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)
- Background: PubMed 19200421van 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.
- Derived from this study: PubMed 20136801van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lamotrigine in people with Bipolar Disorder and Bipolar Depression, run by GlaxoSmithKline at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the MADRS depression rating scale at week 8 compared to baseline. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00224510, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.