Bipolar Depression, Bipolar Disorder
Conditions
Keywords
bipolar disorder bipolar depression lamotrigine
Brief summary
This is a study that, in the first 16 weeks, investigates whether lamotrigine versus placebo offers effect on depressive episodes for patients with bipolar disorder (also known as manic depressive disorder) who use lithium. In the following 50 weeks it is investigated whether these patients experience effect on their depressive and/ or (hypo)manic episodes.
Detailed description
A Multicentre, Double-Blind, Randomised, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine (Lamictal®) compared to placebo as add-on therapy to lithium in the Treatment of Bipolar Depression followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Subjects With Bipolar Disorder
Interventions
DRUGlamotrigine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with bipolar disorder (type I or type II) currently suffering from depression that is at least moderate in severity according to a psychiatrist. * Currently using lithium. * Female subjects can't be pregnant or become pregnant during the study.
Exclusion criteria
* Actively suicidal. * Rapid cyclers. * Suffering from significant personality disorders. * Alcohol or substance dependent or abusive. * Suffering from significant physical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score on the MADRS depression rating scale at week 8 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline | — |
Countries
Netherlands, Spain
Outcome results
None listed