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CompletedNCT00224510

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.

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Check the study details

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  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

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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.

View official study record (opens in a new tab)

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

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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.

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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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