Track topics on Twitter Track topics that are important to you
The objective of this study is to quantitatively examine the efficacy of Seroquel (active ingredient quetiapine fumarate) in subjects with Borderline Personality Disorder (BPD). A secondary objective is to characterize the safety and tolerability of utilizing quetiapine in patients with Borderline Personality Disorder.
Investigator initiated, 6-week, non-placebo controlled, non-randomized, open-label, single drug, single-center, medication trial.
Volunteers (n = 15) diagnosed with Borderline Personality Disorder using the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II).
Subjects with Borderline Personality Disorder are washed out of all other medications. The subjects are then given the study drug at a dose within the drug's known therapeutic range.
Study Design: A six week, open-label, flexible dosing study using quetiapine. Subjects who qualify at Screening will then proceed to the baseline visit. If all inclusion and exclusion criteria are met, subjects will be administered quetiapine at the baseline visit. Enrollment will be 15 subjects. Enrollment is expected to last for a 6 month period.
Study Flow Sheet
Duration of Study and Visit Schedule. The subjects will have visits at the following intervals:
- Screening (Day -1 to -14)
- Visit 1 (Baseline)
- Visit 2 (Week 1)
- Visit 3 (Week 2)
- Visit 4 (Week 3)
- Visit 5 (Week 4)
- Visit 6 (Week 5)
- Visit 7 (Week 6)
Screening visit (Day -1 to -14): The following procedures will be performed:
1. Review of Inclusion and Exclusion criteria
2. Informed consent: Subject will be enrolled after signing an IRB approved informed consent. A signed copy will be given to the subject.
3. Review of Concomitant Medications
4. Medical/Disease History & Physical Exam, Vital Signs: The subject will have a H&P administered by an investigator. Weight, TPR, BP will be assessed. This will be done in Family medicine by Dr. Robert Hudrick, DO or Dr. Andrea Woll, DO.
5. A 12 Lead EKG will be done in Family medicine by Dr. Robert Hudrick, DO or Dr. Andrea Woll, DO.
6. Diagnostic Interview and Psychological Testing: Mental status will be conducted by the investigator and a SCID I and SCID II psychological test will be administered for screening and the Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI-II), Buss-Durkee Hostility Inventory (BDHI), Global Assessment of Functioning (GAF), Symptom Checklist 90 (SCL-90-R) and the Clinical Global Impression Scale (CGI) for severity of illness (Global Improvement and Efficacy not rated) will be utilized to measure the efficacy of quetiapine in this disorder.
7. Lab Parameters: Clinical laboratory samples will be collected and tests will be performed at Kennedy Health System Cherry Hill, NJ. They will be as follows:
A. Comprehensive Metabolic Panel
- total bilirubin
- carbon dioxide
- alkaline phosphatase
- total protein
- SGOT (AST)
- SGPT (ALT)
- urea nitrogen (BUN)
B. Urine Drug Screen
C. Urine HCG in women
F. Electrocardiogram: EKG will screen for heart disease and arrhythmias
8. Subjects who have abnormal laboratory results will be discontinued from the study.
Visit 1 (Baseline).
Review of the following:
- Lab work
- Adverse Events
- Concomitant Medications
- Inclusion and Exclusion Criteria
- Beck Anxiety Inventory (BAI)
- Beck Depression Inventory ( BDI-II)
- Buss-Durkee Hostility Inventory (BDHI)
- Global Assessment of Functioning (GAF)
- Symptom Checklist 90 (SCL-90-R)
- Clinical Global Impression Scale (CGI) for severity of illness (Global Improvement and Efficacy not rated)
- Abnormal Involuntary Movement Scale (AIMS)
- Simpson-Angus Scale
The investigator completes all evaluations and determines the medication dosage.
The study coordinator will then dispense the appropriate number of quetiapine tablets.
Visit 2 (Week 1); Visit 3 (Week 2); Visit 4 (Week 3); Visit 5 (Week 4); Visit 6 (Week 5).
Scales that will be used to assess positive change and medication safety during these visits are:
Scales (in alphabetical order):
- Abnormal Involuntary Movement Scale (AIMS)
- Beck Anxiety Inventory
- Beck Depression Inventory
- Buss-Durkee Hostility Inventory (BDHI)
- Clinical Global Impression (CGI)
- Global Assessment of Functioning GAF
- Simpson-Angus Scale
To be considered for inclusion in this study subject must:
- Provide written informed consent before beginning any study related activities
- Be between age 18 and 55 years
- Be able to speak, read and write English and follow simple instructions for completing self-rated scales
- Meet DSM-IV criteria for BPD as assessed by the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II). Those items screened positive by the subject on the Personality questionnaire will be further evaluated by pertinent subsections of the SKID-II.
Antipsychotic agents other than quetiapine will not be allowed during the study period. Patients who are taking other antipsychotic medication will require at least a three day washout period prior to the baseline visit.
Patients on anticonvulsants, lithium and benzodiazepines will be allowed to enter the study if they have been on the same dose of these agents for three months prior to the baseline visit
How Will the Study Be Analyzed
Laboratory Studies: Studies will be done at baseline and will screen for liver disease, kidney disease, electrolyte imbalance, thyroid or parathyroid dysfunction, respiratory acidosis or alkalosis, anemia, adequate blood cell and platelet count, pregnancy, and presence of illegal drugs. Any subjects with significant laboratory abnormalities will be excluded from the study.
Adverse Events: Subjects will be screened for the following side effects of quetiapine which are dizziness (10%), postural hypotension (7%), dry mouth (7%), and dyspepsia (6%), tachycardia (7%) and somnolence (18%). Patients will be also be monitored for other rare events including seizures, tardive dyskinesia, and neuroleptic malignant syndrome (NMS). Other less common side effects (> 1%) include headache (19% vs placebo 17%), asthenia (3% vs 2%), abdominal pain (3% vs 1%), back pain (2% vs 1%), fever (2% vs 1%), constipation (9% vs 5%),w eight gain (2% vs 0%), rash (4% vs 3%), rhinitis (3% vs 1%), and ear pain (1% vs 0%).
The following will be reported and statistically analyzed:
- Number of patients who begin and complete the study (maximum n = 15).
- Patients who dropout of the study or are terminated with reasons.
- Demographic characteristics of the patients.
- Number of patients who had personality disorders in addition to Borderline Personality Disorder.
- The final average dose of quetiapine.
- The total score and percentage change of each scale and subscale utilized in the study and whether there was a statistically significant increase or reduction during the period of quetiapine administration.
- Movement Disorder side effects as assessed by the Abnormal Involuntary Movement Scale and the Simpson-Angus Scale and whether there was a statistically significant increase or reduction during the period of quetiapine administration.
- The number and percentage of adverse events that occurred during the period of quetiapine administration.
- The number and percentage of any abnormal laboratory results that occurred during the period of quetiapine administration.
After completion of data collection, the data will be analyzed to determine appropriate parametric analyses. As the N for this study will be 15, a T-test analysis may be applicable if the data permit. We anticipate a preliminary demonstration of treatment effect. Individual weekly scores will serve as dependent variables which lend themselves to a one-way analysis to demonstrate difference between baseline and 6 weeks of active treatment. If our data permit, a two-way T-test will also be employed to demonstrate statistically significant differences in treatment effect. As our data will likely require the utilization of multiple two-way analyses, our data will be Bonferroni corrected in order to adjust for the possibility of false positive (type II) errors. Other parametric analyses will be employed as the data warrant.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Borderline Personality Disorder
University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine - Department of Psychiatry
University of Medicine and Dentistry New Jersey
Published on BioPortfolio: 2014-08-27T03:52:51-0400
In patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective in the treatment of psychosis. In patients with borderline personality disorder (BPD), as far a...
Borderline personality disorder (BPD) is the most prevalent personality disorder in young community population whose most severe complication is suicide. Pharmacotherapy should not be used...
The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.
The overall design of the study is to perform both a PET and MRI scan on objectively identified borderline personality disorder patients, to treat them with olanzapine for 8 weeks, and to ...
The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings, impulsivity, ...
Affective dysregulation is widely regarded as being the core problem in patients with borderline personality disorder (BPD). Moreover, BPD is the disorder mainly associated with affective dysregulatio...
This study investigated impulsivity-related personality traits using the Revised NEO Personality Inventory (NEO PI-R) in women diagnosed with co-occurring bulmia nervosa and borderline personality dis...
Borderline Personality Disorder (BPD) is a highly prevalent diagnosis in mental health care and includes a heterogeneous constellation of symptoms. As the field of personality disorder (PD) research m...
After participating in this activity, learners should be better able to:• Evaluate evidence-based therapies for borderline personality disorder
The pathogenesis of borderline personality disorder (BPD) is not well understood. We examined the microstructure of white matter in patients with BPD.
A personality disorder marked by a pattern of instability of interpersonal relationships, self-image, and affects, and marked impulsivity beginning by early adulthood and present in a variety of contexts. (DSM-IV)
A dissociative disorder in which the individual adopts two or more distinct personalities. Each personality is a fully integrated and complex unit with memories, behavior patterns and social friendships. Transition from one personality to another is sudden.
A personality disorder whose essential feature is a pervasive pattern of disregard for, and violation of, the rights of others that begins in childhood or early adolescence and continues into adulthood. The individual must be at least age 18 and must have a history of some symptoms of CONDUCT DISORDER before age 15. (From DSM-IV, 1994)
A personality disorder characterized by the avoidance of accepting deserved blame and an unwarranted view of others as malevolent. The latter is expressed as suspiciousness, hypersensitivity, and mistrust.
A personality disorder characterized by a pervasive and excessive need to be taken care of that leads to submissive and clinging behavior and fears of separation, beginning by early adulthood and present in a variety of contexts. (From DSM-IV, 1994)
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...