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 Depression for manic episodes in bipolarity
This study is completed in the Netherlands and in Spain. It is testing lamotrigine for manic episodes in bipolarity.
Bipolarity, DepressionDrugOver 18 Years
The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.
Where are visits, can any be remote, and how much time is needed?
Costs and support
What costs, reimbursement or compensation apply?
Before joining
Questions to ask before joining
What are the exact eligibility criteria, and what could exclude someone?
How many visits, assessments, or follow-ups are expected, and over what period?
What risks, side effects, practical burdens, or alternatives should be understood first?
Who should be contacted to confirm locations, timing, compensation, and next steps?
Study clarity
Things to check before joining
Study start dateStarted: August 2002
Recruitment status
Completed
Enrollment listed in the registry
120
Sponsor
GlaxoSmithKline
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
Netherlands, Spain
Age range
Over 18 Years
Official registry ID
NCT00224510
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
Check recruitment and locations
Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.
The overall study status can differ from each site's status. Open a country to see its locations and their registry status.
Netherlands · 25 sites
GSK Investigational Site
Alkmaar
Site status: Not listed — confirm with the team
GSK Investigational Site
Almelo
Site status: Not listed — confirm with the team
GSK Investigational Site
Amersfoort
Site status: Not listed — confirm with the team
GSK Investigational Site
Amsterdam
Site status: Not listed — confirm with the team
GSK Investigational Site
Amsterdam
Site status: Not listed — confirm with the team
GSK Investigational Site
Bennebroek
Site status: Not listed — confirm with the team
GSK Investigational Site
Blaricum
Site status: Not listed — confirm with the team
GSK Investigational Site
Delft
Site status: Not listed — confirm with the team
GSK Investigational Site
Dordrecht
Site status: Not listed — confirm with the team
GSK Investigational Site
Eindhoven
Site status: Not listed — confirm with the team
GSK Investigational Site
Enschede
Site status: Not listed — confirm with the team
GSK Investigational Site
Flushing
Site status: Not listed — confirm with the team
GSK Investigational Site
Gouda
Site status: Not listed — confirm with the team
GSK Investigational Site
Groningen
Site status: Not listed — confirm with the team
GSK Investigational Site
Hoorn
Site status: Not listed — confirm with the team
GSK Investigational Site
Leiden
Site status: Not listed — confirm with the team
GSK Investigational Site
Nijmegen
Site status: Not listed — confirm with the team
GSK Investigational Site
Raalte
Site status: Not listed — confirm with the team
GSK Investigational Site
Retranchement
Site status: Not listed — confirm with the team
GSK Investigational Site
Rosmalen
Site status: Not listed — confirm with the team
GSK Investigational Site
The Hague
Site status: Not listed — confirm with the team
GSK Investigational Site
Tilburg
Site status: Not listed — confirm with the team
GSK Investigational Site
Utrecht
Site status: Not listed — confirm with the team
GSK Investigational Site
Weert
Site status: Not listed — confirm with the team
GSK Investigational Site
Zwolle
Site status: Not listed — confirm with the team
Spain · 6 sites
GSK Investigational Site
Alava
Site status: Not listed — confirm with the team
GSK Investigational Site
Barcelona
Site status: Not listed — confirm with the team
GSK Investigational Site
Barcelona
Site status: Not listed — confirm with the team
GSK Investigational Site
Barcelona
Site status: Not listed — confirm with the team
GSK Investigational Site
Madrid
Site status: Not listed — confirm with the team
GSK Investigational Site
Valencia
Site status: Not listed — confirm with the team
Ask HopeStage to help me review this study
This record does not confirm open recruitment. We can help you understand it and explore other studies.
Study ID: NCT00224510. We help you review the study, but cannot decide medical eligibility.
In practice
For you
Participation may contribute to research. Personal benefit is not guaranteed.
Ask the research team to explain the activities, time commitment, and follow-up involved.
Study sites are listed. Confirm the relevant site and any travel before making plans.
Important
Not medical advice
Information from public sources.
Are you the study sponsor? Contact us to update this page: hi@hopestage.com
FAQ
Questions about this study
What is this study trying to understand?
This study is exploring medication or study treatment for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.
Does this study involve a medication?
This appears to be a medication / drug study involving lamotrigine. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.
Who might this study be for?
This study may concern people with bipolarity; age range: Over 18 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.
What would I likely need to do?
You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.
Will I need to change, stop, or stabilize my current treatment?
The public registry appears to mention rules about current treatment, stability, stopping treatment, or dose changes. Do not change your treatment for a study without medical guidance. Ask the study team and your clinician what is required, what is not allowed, and how safety is monitored.
Will I need to travel or attend in-person visits?
The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.
Who is behind this study?
This study is sponsored by GlaxoSmithKline, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.
Can I still join this study?
The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.
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This EU register entry describes an interventional medicine trial, designed to assign participants a study treatment. The protocol sets out the treatment, eligibility criteria and assessments. Check the source details below for country statuses and any transfer to CTIS.