amotrigine And Borderline Personality Disorder: Investigating Long-Term Effectiveness

Phase 1

• Conditions: Borderline Personality Disorder; MedDRA version: 14.1 Level: PT Classification code 10042033 Term: Stevens-Johnson syndrome System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 14.1 Level: PT Classification code 10019211 Term: Headache System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 15.0 Level: LLT Classification code 10028821 Term: Nausea with vomiting System Organ Class: 100000004856; MedDRA version: 14.1 Level: LLT Classification code 10040913 Term: Skin rash System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 14.1 Level: PT Classification code 10024264 Term: Lethargy System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1 Level: LLT Classification code 10013649 Term: Drowsiness System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-003136-23-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-16
• Study Completion: 2016-09-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 276

Inclusion Criteria

Inclusion Criteria: - Age 18 and over. - Fulfilling DSM-IV diagnostic criteria for Borderline Personality Disorder. - Competent and willing to provide written, informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion Criteria: - Currently fulfilling criteria for Bipolar affective disorder (type I & II), or psychotic disorder (schizophrenia, schizoaffective disorder, or mood disorder with psychotic features). - At present receiving a mood stabiliser(s) (e.g lithium, carbamazepine, or valproate)*. - Known medical history of liver or kidney impairment. - Cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures. - Any woman who is pregnant or planning a pregnancy, and any woman of child bearing potential unless using adequate contraception. This will be established using structured questioning at screening and follow-up, and documented in the case report form. - Participation in any other clinical trial within the past 4 months. *Participants will be required to discontinue any mood stabiser(s) (e.g. lithium, carbamazepine, or valproate) for at least four weeks before entry into the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified