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Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)

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ClinicalTrials.gov Identifier: NCT00880919
Recruitment Status : Completed
First Posted : April 14, 2009
Results First Posted : December 28, 2016
Last Update Posted : March 9, 2017
Sponsor:
Collaborators:
AstraZeneca
University of Iowa
Mclean Hospital
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Borderline Personality Disorder
Interventions Drug: quetiapine extended-release
Drug: Placebo
Enrollment 95
Recruitment Details This randomized, double-blind, placebo-controlled, dose comparison trial was conducted at three outpatient treatment centers from January 2010 to March 2013.
Pre-assignment Details Ninety-five persons with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) borderline personality disorder (BPD) were randomly assigned to quetiapine XR 150 mg/day (n=33), quetiapine XR 300 mg/day (n=33), or placebo (n=29).
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Hide Arm/Group Description Seroquel XR 150mg oral tablets taken daily for 8 weeks. Seroquel XR 300mg oral tablets taken daily for 8 weeks. Equivalent number of placebo oral tablets taken daily for 8 weeks.
Period Title: Overall Study
Started 33 33 29
Completed 18 19 23
Not Completed 15 14 6
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29). Total
Hide Arm/Group Description Seroquel XR 150mg oral tablets taken daily for 8 weeks. Seroquel XR 300mg oral tablets taken daily for 8 weeks. Equivalent number of placebo oral tablets taken daily for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 33 33 29 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 29 participants 95 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
 100.0%
33
 100.0%
29
 100.0%
95
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 33 participants 29 participants 95 participants
28.2  (8.0) 30.2  (8.1) 20.1  (8.8) 29.5  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 29 participants 95 participants
Female
25
  75.8%
23
  69.7%
19
  65.5%
67
  70.5%
Male
8
  24.2%
10
  30.3%
10
  34.5%
28
  29.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 33 participants 29 participants 95 participants
33 33 29 95
1.Primary Outcome
Title Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)
Hide Description This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.
Time Frame baseline, weekly until week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Hide Arm/Group Description:
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
Equivalent number of placebo oral tablets taken daily for 8 weeks.
Overall Number of Participants Analyzed 33 33 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.22  (0.15) -0.99  (0.16) -0.75  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Quetiapine XR 150 mg/Day (n=33),, Quetiapine XR 300 mg/Day (n=33),, Placebo (n=29).
Comments Mean changes were calculated using each groups linear and quadratic effects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .015
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Montgomery–Åsberg Depression Rating Scale (MADRS)
Hide Description

Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest

0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression.

Time Frame baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Arm/Group Title Quetiapine XR 150 mg/Day (n=33) Quetiapine XR 300 mg/Day (n=33) Placebo (n=29)
Hide Arm/Group Description:

Seroquel XR 150mg oral tablets taken daily for 8 weeks.

quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo

Seroquel XR 300mg oral tablets taken daily for 8 weeks.

quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo

Equivalent number of placebo oral tablets taken daily for 8 weeks.

Placebo: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo

Overall Number of Participants Analyzed 33 33 29
Mean (Standard Error)
Unit of Measure: units on a scale
-0.85  (0.19) -1.05  (0.19) -0.59  (0.18)
3.Primary Outcome
Title Borderline Evaluation of Severity Over Time (BEST)
Hide Description Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Hide Arm/Group Description:
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
Equivalent number of placebo oral tablets taken daily for 8 weeks.
Overall Number of Participants Analyzed 33 33 29
Mean (Standard Error)
Unit of Measure: units on a scale
-2.10  (0.32) -1.97  (0.33) -0.91  (0.31)
4.Primary Outcome
Title Overt Aggression Scale - Modified (OAS-M)
Hide Description Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms.
Time Frame Change from Baseline Overt Aggression Scale - Modified to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Hide Arm/Group Description:
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
Equivalent number of placebo oral tablets taken daily for 8 weeks.
Overall Number of Participants Analyzed 33 33 29
Mean (Standard Error)
Unit of Measure: units on a scale
-1.92  (0.42) -1.82  (0.43) -0.37  (0.43)
5.Primary Outcome
Title Global Assessment of Functioning Scale (GAF)
Hide Description Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional
Time Frame Change in Global Assessment of Functioning from Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Hide Arm/Group Description:
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
Equivalent number of placebo oral tablets taken daily for 8 weeks.
Overall Number of Participants Analyzed 33 33 29
Mean (Standard Error)
Unit of Measure: units on a scale
1.05  (0.20) 1.04  (0.21) 0.62  (0.19)
6.Primary Outcome
Title Barratt Impulsiveness Scale (BIS)
Hide Description 30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.
Time Frame Change in Impulsiveness from Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Hide Arm/Group Description:
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
Equivalent number of placebo oral tablets taken daily for 8 weeks.
Overall Number of Participants Analyzed 33 33 29
Mean (Standard Error)
Unit of Measure: units on a scale
-0.73  (0.27) -0.83  (0.27) -.59  (0.26)
7.Primary Outcome
Title Symptom Checklist -90-Revised (SCL-90-R)
Hide Description 90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms
Time Frame Change in psychological problems and symptoms from Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Hide Arm/Group Description:
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
Equivalent number of placebo oral tablets taken daily for 8 weeks.
Overall Number of Participants Analyzed 33 33 29
Mean (Standard Error)
Unit of Measure: units on a scale
-0.11  (0.02) -0.12  (0.02) -0.07  (0.02)
8.Primary Outcome
Title Young Mania Rating Scale (YMS)
Hide Description Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms
Time Frame Change in manic symptoms from Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Hide Arm/Group Description:
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
Equivalent number of placebo oral tablets taken daily for 8 weeks.
Overall Number of Participants Analyzed 33 33 29
Mean (Standard Error)
Unit of Measure: units on a scale
-0.26  (0.06) -0.30  (0.06) 0.11  (0.06)
9.Primary Outcome
Title Sheehan Disability Scale (SDS)
Hide Description Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment
Time Frame Change in functional impairment from Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Hide Arm/Group Description:
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
Equivalent number of placebo oral tablets taken daily for 8 weeks.
Overall Number of Participants Analyzed 33 33 29
Mean (Standard Error)
Unit of Measure: units on a scale
-0.85  (0.19) -1.11  (0.20) 0.58  (0.18)
Time Frame 10 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Hide Arm/Group Description Seroquel XR 150mg oral tablets taken daily for 8 weeks. Seroquel XR 300mg oral tablets taken daily for 8 weeks. Equivalent number of placebo oral tablets taken daily for 8 weeks.
All-Cause Mortality
Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/33 (0.00%)      0/33 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine XR 150 mg/Day (n=33), Quetiapine XR 300 mg/Day (n=33), Placebo (n=29).
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/33 (87.88%)      30/33 (90.91%)      19/29 (65.52%)    
Gastrointestinal disorders       
Nausea or vomiting   4/33 (12.12%)  4 4/33 (12.12%)  4 4/29 (13.79%)  4
General disorders       
Dry mouth   9/33 (27.27%)  9 14/33 (42.42%)  14 1/29 (3.45%)  1
Headache   7/33 (21.21%)  7 10/33 (30.30%)  10 6/29 (20.69%)  6
Hypersomnia   5/33 (15.15%)  5 8/33 (24.24%)  8 2/29 (6.90%)  2
Dizziness   5/33 (15.15%)  5 7/33 (21.21%)  7 1/29 (3.45%)  1
Metabolism and nutrition disorders       
Change in appetite   9/33 (27.27%)  9 12/33 (36.36%)  12 4/29 (13.79%)  4
Musculoskeletal and connective tissue disorders       
Bodily pain   6/33 (18.18%)  6 9/33 (27.27%)  9 5/29 (17.24%)  5
Nervous system disorders       
Sedation   29/33 (87.88%)  29 30/33 (90.91%)  30 19/29 (65.52%)  19
Forgetfulness or confusion   5/33 (15.15%)  5 7/33 (21.21%)  7 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. S. Charles Schulz, MD
Organization: University of Minnesota
Phone: 612-273-9820
EMail: scs@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00880919     History of Changes
Other Study ID Numbers: 0709M16844
IRUSQUET0454 ( Other Grant/Funding Number: AstraZeneca )
First Submitted: April 10, 2009
First Posted: April 14, 2009
Results First Submitted: April 16, 2014
Results First Posted: December 28, 2016
Last Update Posted: March 9, 2017