CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 28 enrolled
Drug / intervention
Lamotrigine +1 moredrug
Likely dose
Lamotrigine 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00634062
NCT00634062Phase 4Completed
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Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Mclean Hospital·interventional·Posted Mar 12, 2008·Updated Mar 12, 2008

In Brief

A Phase 4 clinical trial evaluating Lamotrigine and Placebo for Borderline Personality Disorder. Completed, enrolled 28 participants across 1 site.

Detailed Summary

This study investigates the hypothesis that instability in mood in patients with borderline personality disorder will respond the mood stabilizing medication lamotrigine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBorderline Personality Disorder
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2008
Enrollment StartDec 1, 2004
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.3 years ago

Interventions

Lamotriginedrug

Subject in active active drug group will receive lamotrigine tablets 12.5 per day for the first week of the study. Dose of lamotrigine can be increased to 25mg per day during the second week of the study and may be increased each week thereafter for the next 9 weeks by 25mg per day. Subjects in active treatment group will receive lamotrigine for total of 12 weeks

Placebodrug

Subjects will receive 12.5mg of inert placebo per day during the first week of the study. Inert placebo can be increased to 25mg per day during the second week of the study and by 25mg per day each week for the next 9 weeks. Subjects can receive a total of 12 weeks of placebo.