Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
Brief Summary: This study investigates the hypothesis that instability in mood in patients with borderline personality disorder will respond the mood stabilizing medication lamotrigine.


Options:
A: Inclusion Criteria:

* Patients must be of outpatient status at Visit 1 and through Visit 2
* Patients must be 18 through 65 years of age at Visit 1
* Patients must meet all of the DSM-IV-TR General Diagnostic Criteria for a Personality Disorder AND Patients must meet DSM-IV-TR diagnostic criteria for BPD as determined by the DIPD-IV, confirmed by a psychiatrist with training in the evaluation and assessment of BPD.
* The symptom severity as assessed by the total score of the ZAN-BPD, confirmed by a psychiatrist with training in the evaluation and assessment of BPD, must be greater than or equal to 9 at Visit 2.
* Female patients of childbearing potential must test negative for pregnancy and must be using medically accepted means of contraception throughout the study. Use of any oral or injectable contraception must be initiated prior to Visit 2.

Exclusion Criteria:

* Investigators, study site personnel directly affiliated with the study, or immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Persons employed by Lilly (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
* Have previously participated (have been randomized) or withdrawn from this study or any other Lilly sponsored study investigating olanzapine.
* Have had previous treatment with olanzapine unless, in the opinion of the investigator, the patient's previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of olanzapine was confounded by concomitant medication.
* Female patients who are either pregnant or nursing.
B: Inclusion Criteria:

* Male or female participants, ages 18 to 65, inclusive, at the time of informed consent
* Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of BPD confirmed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) at screening.
* At screening and Day 0, participants must have a total score ≥ 12 on the Zanarini Rating Scale for BPD (ZAN-BPD) scale.
* Participants who, in the investigator's judgment, require treatment with a medication for BPD.
* Participants willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.

Exclusion Criteria:

* Sexually active males or females of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (IMP). Consensual sexual activity that cannot biologically result in pregnancy may not be participant to required birth control methods, following discussion with the medical monitor. Male participants must also agree not to donate sperm from trial screening through 30 days after the last dose of IMP.
* Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
* Participants with a concurrent DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Also, participants with a concurrent diagnosis of bipolar I disorder, bipolar II disorder, delirium, dementia, amnesia, eating disorder, antisocial personality disorder, or other cognitive disorders.
* Participants with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit.
* Participants who fulfill the following criteria related to suicide and/or suicidal ideation are excluded:

  * Participants who have a significant risk of committing violent acts, serious self-harm, or suicide based on history or routine psychiatric status examination, or those who are homicidal or considered to be a high risk to others, or participants with a response of "yes" on the Columbia-suicide severity rating scale (C-SSRS) Suicidal Ideation Item 5, OR
  * Participants with a response of "yes" on the C-SSRS Suicidal Behavior Items, OR
  * Participants who have had 3 suicide attempts, OR,
  * Participants who have had 3 or more hospitalizations due to suicidal behavior.
* Participants who received brexpiprazole in any prior clinical trial or participants who have taken or are taking commercially available brexpiprazole (Rexulti®).
* Participants who are currently either inpatient or partially hospitalized.
* Participants who participated in a clinical trial within 90 days prior to screening or who participated in more than 2 clinical trials within a year prior to screening.
C: Inclusion Criteria:

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

Exclusion Criteria:

* 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
D: Inclusion Criteria:

* Diagnosed with PTSD (309.81), and
* Diagnosed with a borderline personality disorder (301.83) or at least 4 BPD symptoms

To be eligible for the study, both patients and healthy controls (for the MRI scans) have to:

* Be aged between 18 and 65 years
* Give written informed consent
* Speak / understand Dutch sufficiently

Exclusion criteria:

* Current psychosis
* Comorbidity interfering with treatment or randomisation (severe outward aggression, antisocial PD, treatment interfering addiction or eating disorders, somatic problems)
* Primary diagnosis of paranoid, schizoid, schizotypal, narcissistic, histrionic or antisocial PD
* Mental retardation

Additional exclusion criteria for the MRI substudy are:

* Pregnancy
* Metal implants (such as pacemakers, etc.);
* Somatic disorders interfering with brain functioning
* Claustrophobia
* High dose use of benzodiazepines

For the healthy controls, current psychiatric diagnosis is an additional exclusion criterion.

Answer: C