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Study ID: NCT00224510. We help you review the study, but cannot decide medical eligibility.
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 focuses on manic episodes in bipolarity.
Bipolarity, DepressionDrugOver 18 Years
Key information made simple
This summary needs review. Please check the official study record and contact the research team for details.
Your next step
The official record suggests in-person participation through a research setting, with sites including GSK Investigational Site in Alkmaar, GSK Investigational Site in Almelo, and GSK Investigational Site in Amersfoort. Participation appears to involve guided sessions or support activities with check-ins on how they fit into daily life. The main fit is usually meeting the main study requirements, while common reasons not to take part include safety concerns that need urgent care first and active substance or alcohol problems that could affect the results. This is a later-stage study, which usually means a larger group and a closer look at how well the approach holds up.
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?
Things to check before joining
Study start dateStarted: August 2002
- Recruitment status
- Completed
- Estimated enrollment
- Not clearly listed
- Sponsor
- GlaxoSmithKline
- Sponsor type
- Unknown or unclear
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Not clearly listed
- 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
- Official source
- Official registry link
Want help reviewing this study?
Study ID: NCT00224510. We help you review the study, but cannot decide medical eligibility.
For you
Taking part may give access to a new approach being evaluated.
It requires regular visits and structured follow-up.
Requires travel, with in-person participation in Netherlands.
Not medical advice
Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com
Questions about this study
What is this study trying to understand?
This study is exploring behavioral or lifestyle intervention 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. The phase is not clearly listed in the public registry. Phase is mostly relevant for medication studies and some device studies. For this study, it may be more useful to look at what is required, the duration, visits, and eligibility criteria.
Do I need to want to stop or reduce tobacco use to participate?
The public registry appears to mention tobacco, nicotine, alcohol, cannabis, or another addiction-related topic. Ask the study team whether you need to want to stop, reduce, already be abstinent, or simply meet use-related criteria. Eligibility must be confirmed by the study team.
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 registry indicates that this study is completed. It may still be useful for understanding the research, but you are unlikely to be able to join.
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