Last updated: 03/05/2025 07:20:26
Meta-analysis of lamotrigine maintenance studies in a subgroup of women (18-45 years) with bipolar I disorder
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Meta-analysis to evaluate the efficacy and safety of lamotrigine versus placebo in a sub-group of women with bipolar I disorder (WBD) of childbearing age (18-45 years) from four maintenance studies
Trial description: The purpose of this meta-analysis is to retrospectively examine the risk-benefit of lamotrigine versus placebo in women of childbearing age with bipolar I disorder who participated in four similar, maintenance studies that assessed time to intervention for an emerging mood episode (manic/hypomanic/mixed or depressed).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Time to intervention for any mood episode (TIME)
Timeframe: Up to 76 weeks
Secondary outcomes:
TIME to a first mood event requiring treatment for depression (TiDep)
Timeframe: Up to 76 weeks
TIME to a first mood event requiring treatment for mania (TiMan)
Timeframe: Up to 76 weeks
Percentage of participants with Adverse event (AE) and AE leading to study discontinuation
Timeframe: Up to 76 weeks
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-10-03
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Eduard Vieta, Sanman Ghorpade, Arunangshu Biswas, Angshuman Sarkar, Abhay Phansalkar, James Cooper. Lamotrigine efficacy, safety, and tolerability for women of childbearing age with bipolar I disorder: Meta-analysis from four randomized, placebo-controlled maintenance studies.. European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology. 2024-Jan;78: 81-92.
DOI: 10.1016/j.euroneuro.2023.09.001
PMID: 37775363
Medical condition
Epilepsy, Bipolar Affective Disorders (Acute Mania)
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
October 2021 to March 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18 - 45 Years
Accepts healthy volunteers
No
- Women of childbearing age (18-45 years) with Bipolar I Disorder receiving lamotrigine or placebo during the randomized, double-blind maintenance phase of the four clinical studies will be included in this analysis.
- Women above the age of 45 years.
- Men with Bipolar I Disorder.
Inclusion and exclusion criteria
Inclusion criteria:
- Women of childbearing age (18-45 years) with Bipolar I Disorder receiving lamotrigine or placebo during the randomized, double-blind maintenance phase of the four clinical studies will be included in this analysis.
Exclusion criteria:
- Women above the age of 45 years.
- Men with Bipolar I Disorder.
- Female participants randomized to lithium group in the International studies will be excluded. Lithium group is excluded from this analysis since this treatment group was not included in Chinese and Japanese studies.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
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
2022-10-03
Actual study completion date
2022-10-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website