Last updated: 11/04/2018 11:36:39
Bipolar Study in Adults at Least 18 Years of Age
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Lamictal for use in treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness.
Trial description: Bipolar study of tolerability, clinical response and patient satisfaction
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
The primary endpoint will be the rate of rash during 12 weeks.
Timeframe: 12 Weeks
Secondary outcomes:
Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores.
Timeframe: 12 Weeks
Interventions:
Enrollment:
1200
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Bipolar Disorder
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
August 2003 to August 2004
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Diagnosis of bipolar I disorder.
- Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
- Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of bipolar I disorder.
- Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
- If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
Exclusion criteria:
- Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
- Presence of untreated thyroid disease.
- Patient is actively suicidal or homicidal.
- Patient has history of severe hepatic or renal insufficiency.
- Patient is currently participating in another clinical trial.
Trial location(s)
Location
GSK Investigational Site
La Mesa, California, United States, 91941
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95825
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cerritos, California, United States, 90703
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Terminated/Withdrawn
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Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2004-05-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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