E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Borderline Personality Disorder |
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E.1.1.1 | Medical condition in easily understood language |
People with borderline personality disorder experience high levels of emotional distress and often experience other problems including negative feelings about themselves and rapid changes in mood. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042033 |
E.1.2 | Term | Stevens-Johnson syndrome |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019211 |
E.1.2 | Term | Headache |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028821 |
E.1.2 | Term | Nausea with vomiting |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040913 |
E.1.2 | Term | Skin rash |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10024264 |
E.1.2 | Term | Lethargy |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013649 |
E.1.2 | Term | Drowsiness |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The principal aim is to investigate the clinical and cost-effectiveness of adding lamotrigine to usual care for adults with Borderline Personality Disorder. To achieve this, we will: - Test whether adding lamotrigine to usual care for adults with Borderline Personality Disorder improves mental health over a 52 week period, in comparison to a placebo control. - Examine whether the addition of lamotrigine to usual care for adults with Borderline Personality Disorder improves social functioning and quality of life, reduces the incidence of suicidal behaviour, and lowers the amount of antipsychotic and other psychotropic medication that people are prescribed, in comparison to a placebo control. - Compare the incidence of side effects among those prescribed lamotrigine in addition to usual care for adults with Borderline Personality Disorder, in comparison to a placebo control. - Examine the cost, cost-utility and cost-effectiveness of adding lamotrigine to usual care for a |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is symptoms of Borderline Personality Disorder measured at 52 weeks using the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD). The ZAN-BPD is a widely used measure of symptoms and behavioural problems experienced by people with BPD. It includes measures of anger, impulsivity and affective instability. The ZAN-BPD has been used in previous studies of pharmacological and psychological treatments for people with BPD and is sensitive to change. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Total score on the ZAN-BPD at baseline, 12 and 24 weeks; - Depression: depressive symptoms will be assessed using the 21-item Beck Depression Inventory at baseline, 12, 24 and 52 weeks. The Beck Depression Inventory has been widely used as a self-complete questionnaire, providing a valid assessment of the severity of depressive symptoms and can be completed in less than 10 minutes. - Self-harm: incidence and severity of suicidal behaviour will be assessed using the Acts of Deliberate Self-Harm Inventory at baseline, 12, 24 and 52 weeks. This structured interview collects detailed information about the number and severity of episodes of self-harm and has been used successfully in other trials of treatments for people with BPD31. - Social functioning: social functioning will be assessed using the Social Functioning Questionnaire at baseline, 12, 24 and 52 weeks. The questionnaire is an eight-item self-report scale that asks people about problems across a range of settings that people with personality disorder often experience. - Health-related quality of life: health related quality of life will be assessed using the Euro-QOL-5D (EQ-5D) at baseline, 12, 24 and 52 weeks. The EQ-5D provides a brief and reliable measure of health-related quality of life which is responsive to change in people with BPD. - Side effect scale: possible side effects of lamotrigine will be assessed using a proforma designed to cover the possible effects listed in the British National Formulary (BNF) entry for lamotrigine, at baseline, 12, 24, and 52 weeks. - Service use: resource use will be collected using a modified version of the Adult Service Use Schedule at baseline, 12, 24 and 52 weeks. This questionnaire collects detailed data on use of all hospital and community health and social care services including medication. - Medication adherence: to assess medication adherence at 12, 24 and 52 weeks the Morisky Scale shall be utilized. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will finish once the last/final participant ceases to take the study medication, whether this is due to them reaching the end of the participation period (54 weeks), withdrawal or other reason. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |