NCT00634062

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

Enrollment Period

2.8 years

First QC Date

March 4, 2008

Last Update Submit

March 11, 2008

Conditions

Borderline Personality Disorder

Keywords

Affective LabilityBorderline Personality DisorderPharmacotherapy

Outcome Measures

Primary Outcomes (2)

  • Changes in score of Affective Lability Scale

    Baseline and then weekly for 12 weeks

  • Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder

    Baseline and then weekly for 12 weeks

Secondary Outcomes (1)

  • Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder

    Baseline and then weekly for 12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Lamotrigine

2

PLACEBO COMPARATOR
Drug: Placebo

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

Also known as: Lamictal
1
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.

2

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical Diagnosis of Borderline Personality Disorder with high levels of emotional instability

You may not qualify if:

  • Clinical diagnosis of Bipolar Disorder
  • Clinical diagnosis of psychiatric disorder related to general medical condition
  • Clinical diagnosis of substance abuse disorder within the last 60 days
  • Clinical diagnosis of psychotic disorder
  • Previous treatment with lamotrigine
  • Pregnancy or nursing
  • Currently hospitalized
  • Active suicidal or homicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (4)

  • Weinstein W, Jamison KL. Retrospective case review of lamotrigine use for affective instability of borderline personality disorder. CNS Spectr. 2007 Mar;12(3):207-10. doi: 10.1017/s1092852900020927.

    PMID: 17329981BACKGROUND

  • Tritt K, Nickel C, Lahmann C, Leiberich PK, Rother WK, Loew TH, Nickel MK. Lamotrigine treatment of aggression in female borderline-patients: a randomized, double-blind, placebo-controlled study. J Psychopharmacol. 2005 May;19(3):287-91. doi: 10.1177/0269881105051540.

    PMID: 15888514BACKGROUND

  • Pinto OC, Akiskal HS. Lamotrigine as a promising approach to borderline personality: an open case series without concurrent DSM-IV major mood disorder. J Affect Disord. 1998 Dec;51(3):333-43. doi: 10.1016/s0165-0327(99)00007-5.

    PMID: 10333987BACKGROUND

  • Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.

    PMID: 36375174DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TriazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • D. Bradford Reich, M.D.

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 12, 2008

Study Start

December 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

US(1)