Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122070
Status:
COMPLETED
Last Update Posted:
2008-06-10
First Post:
2005-07-15
Brief Title:
Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 drugs known therapeutic range
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 drugs known therapeutic range
Detailed 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 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 MedicalDisease History Physical Exam Vital Signs The subject will have a HP 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
albumin
total bilirubin
calcium
carbon dioxide
chloride
creatinine
glucose
alkaline phosphatase
potassium
total protein
sodium
SGOT AST
SGPT ALT
urea nitrogen BUN
B Urine Drug Screen
amphetamines
barbiturates
benzo
cocaine
opiate
PCP
cannabinoids
C Urine HCG in women
D TSH
E CBCDifferential
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
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
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
Inclusion Criteria
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
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 5w 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
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
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 MedicalDisease History Physical Exam Vital Signs The subject will have a HP 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
albumin
total bilirubin
calcium
carbon dioxide
chloride
creatinine
glucose
alkaline phosphatase
potassium
total protein
sodium
SGOT AST
SGPT ALT
urea nitrogen BUN
B Urine Drug Screen
amphetamines
barbiturates
benzo
cocaine
opiate
PCP
cannabinoids
C Urine HCG in women
D TSH
E CBCDifferential
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
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
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
Inclusion Criteria
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
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 5w 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRUS QUET 0246 | None | None | None |