Status and phase
Conditions
Treatments
About
Objective:
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.
Design:
Investigator initiated, 6-week, non-placebo controlled, non-randomized, open-label, single drug, single-center, medication trial.
Participants:
Volunteers (n = 15) diagnosed with Borderline Personality Disorder using the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II).
Interventions:
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.
Full description
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 visit (Day -1 to -14): The following procedures will be performed:
Review of Inclusion and Exclusion criteria
Informed consent: Subject will be enrolled after signing an IRB approved informed consent. A signed copy will be given to the subject.
Review of Concomitant Medications
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.
A 12 Lead EKG will be done in Family medicine by Dr. Robert Hudrick, DO or Dr. Andrea Woll, DO.
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.
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
B. Urine Drug Screen
C. Urine HCG in women
D. TSH
E. CBC/Differential
F. Electrocardiogram: EKG will screen for heart disease and arrhythmias
Subjects who have abnormal laboratory results will be discontinued from the study.
Visit 1 (Baseline).
Review of the following:
Study Medication:
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):
Inclusion Criteria:
To be considered for inclusion in this study subject must:
Concomitant Therapy
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%).
Data Analysis
The following will be reported and statistically analyzed:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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