Comparison of Low and Moderate Dosages of Extended-Release Quetiapine in Borderline Personality Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial
Abstract
Objective:
Method:
Results:
Conclusions:
Method
Inclusion and Exclusion Criteria
Efficacy Assessments
Safety Measures
Statistical Analysis
Results
Variable | Placebo (N=29) | Low-Dosage Quetiapine (150 mg/day) (N=33) | Moderate-Dosage Quetiapine (300 mg/day) (N=33) | |||
---|---|---|---|---|---|---|
Mean | SD | Mean | SD | Mean | SD | |
Age (years) | 30.1 | 8.8 | 28.2 | 8.0 | 30.2 | 8.1 |
Age at onset (years) | 14.6 | 6.6 | 12.2 | 3.7 | 12.2 | 5.0 |
Duration of illness (years) | 16.2 | 8.9 | 15.4 | 9.4 | 17.9 | 8.5 |
Education (years) | 14.5 | 1.7 | 14.3 | 2.7 | 14.1 | 3.0 |
N | % | N | % | N | % | |
Male | 10 | 34 | 8 | 24 | 10 | 30 |
Race/ethnicity | ||||||
European-Caucasian | 22 | 79 | 26 | 79 | 26 | 79 |
Other | 6 | 21 | 7 | 21 | 7 | 21 |
Marital status | ||||||
Single | 20 | 74 | 26 | 79 | 18 | 56 |
Married | 2 | 7 | 4 | 12 | 6 | 19 |
Other | 5 | 19 | 3 | 9 | 8 | 25 |
Any past psychiatric hospitalization | 7 | 24 | 13 | 39 | 13 | 39 |
Lifetime psychiatric axis I disorders | ||||||
Mood disorders | 14 | 48 | 25 | 76 | 19 | 58 |
Anxiety disorders | 5 | 17 | 5 | 15 | 5 | 15 |
Substance use disorders | 6 | 21 | 11 | 33 | 13 | 39 |
Any axis I disorder | 19 | 66 | 29 | 88 | 28 | 85 |
Placebo (N=29) | Low-Dosage Quetiapine (150 mg/day) (N=33) | Moderate-Dosage Quetiapine (300 mg/day) (N=33) | Analysis | ||||||
---|---|---|---|---|---|---|---|---|---|
Measure | Mean | SD | Mean | SD | Mean | SD | F | df | p |
Zanarini scalea | |||||||||
Total score | 14.6 | 4.8 | 15.8 | 3.4 | 17.7 | 5.3 | 3.7 | 2,92 | 0.029 |
Affective disturbance score | 6.3 | 2.0 | 6.4 | 1.3 | 7.2 | 1.8 | 2.5 | 2,92 | 0.092 |
Cognitive disturbance score | 3.1 | 1.7 | 3.5 | 1.4 | 4.0 | 1.9 | 2.1 | 2,92 | 0.130 |
Impulsivity score | 1.7 | 0.9 | 1.8 | 1.1 | 2.2 | 1.3 | 2.2 | 2,92 | 0.115 |
Disturbed relationship score | 3.5 | 1.4 | 4.0 | 1.4 | 4.3 | 1.5 | 2.4 | 2,92 | 0.093 |
Zanarini scale,a self-rated | |||||||||
Total score | 11.8 | 6.6 | 14.4 | 5.1 | 17.8 | 6.3 | 7.7 | 2,92 | 0.001 |
Affective disturbance score | 5.3 | 2.5 | 6.1 | 2.2 | 7.7 | 2.5 | 7.7 | 2,91 | 0.001 |
Cognitive disturbance score | 2.4 | 2.2 | 3.1 | 2.2 | 3.7 | 2.1 | 2.5 | 2,91 | 0.088 |
Impulsivity score | 1.5 | 1.4 | 1.5 | 1.3 | 2.3 | 1.6 | 2.9 | 2,91 | 0.061 |
Disturbed relationship score | 2.6 | 1.8 | 3.8 | 1.7 | 4.2 | 2.2 | 5.7 | 2,91 | 0.005 |
Borderline Evaluation of Severity Over Time | |||||||||
Total score | 32.6 | 10.6 | 36.6 | 9.6 | 40.9 | 12.0 | 4.6 | 2,92 | 0.013 |
Thoughts and feelings score | 18.7 | 7.1 | 21.7 | 6.1 | 24.2 | 8.0 | 4.5 | 2,92 | 0.014 |
Negative behaviors score | 7.1 | 2.7 | 8.8 | 3.0 | 9.9 | 3.8 | 5.8 | 2,92 | 0.004 |
Positive behaviors score | 8.3 | 3.0 | 8.9 | 2.5 | 8.2 | 2.5 | 0.7 | 2,92 | 0.505 |
Montgomery-Åsberg Depression Rating Scale | 15.0 | 6.7 | 16.9 | 5.6 | 18.8 | 7.2 | 2.7 | 2,91 | 0.075 |
Modified Overt Aggression Scale | 11.3 | 9.2 | 18.7 | 14.9 | 22.6 | 17.8 | 4.7 | 2,91 | 0.011 |
Young Mania Rating Scale | 3.6 | 2.9 | 3.3 | 2.8 | 4.4 | 3.6 | 1.1 | 2,91 | 0.346 |
Global Assessment of Functioning Scale | 62.3 | 6.0 | 61.1 | 7.9 | 58.4 | 6.4 | 2.6 | 2,91 | 0.078 |
Barratt Impulsiveness Scale | 74.8 | 9.3 | 71.7 | 14.5 | 79.9 | 17.4 | 2.7 | 2,91 | 0.070 |
Symptom Checklist–90–Revised | 1.0 | 0.7 | 1.3 | 0.6 | 1.7 | 0.7 | 7.3 | 2,91 | 0.001 |
Sheehan Disability Scale | |||||||||
Total score | 13.0 | 5.5 | 16.7 | 5.2 | 17.2 | 6.2 | 4.8 | 2,91 | 0.010 |
Work/school | 3.3 | 2.1 | 4.5 | 2.7 | 5.3 | 2.8 | 4.2 | 2,81 | 0.019 |
Social life | 0.1 | 0.3 | 0.1 | 0.4 | 0.2 | 0.4 | 0.6 | 2,79 | 0.538 |
Family life/home responsibilities | 4.9 | 2.4 | 6.0 | 2.4 | 6.3 | 2.5 | 2.9 | 2,92 | 0.058 |
Days lost | 5.2 | 2.3 | 6.6 | 2.2 | 6.3 | 2.7 | 3.0 | 2,92 | 0.054 |
Days unproductive | 1.2 | 1.7 | 4.0 | 6.5 | 5.6 | 7.6 | 4.2 | 2,87 | 0.018 |
Adverse Events
Placebo (N=29) | Low-Dosage Quetiapine (150 mg/day) (N=33) | Moderate-Dosage Quetiapine (300 mg/day) (N=33) | Total | Related to Study Drug | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Event | N | % | N | % | N | % | N | % | N | % |
Any adverse event | 25 | 86 | 29 | 88 | 30 | 91 | 84 | 88 | 78 | 82 |
Sedation | 15 | 52 | 25 | 76 | 28 | 85 | 68 | 71 | 67 | 70 |
Change in appetite | 4 | 14 | 9 | 27 | 13 | 39 | 26 | 27 | 25 | 26 |
Dry mouth | 1 | 3 | 9 | 27 | 14 | 42 | 24 | 25 | 24 | 25 |
Headache | 8 | 28 | 7 | 21 | 13 | 39 | 28 | 29 | 23 | 24 |
Bodily pain | 12 | 41 | 11 | 33 | 12 | 36 | 35 | 37 | 20 | 21 |
Hypersomnia | 3 | 10 | 5 | 15 | 8 | 24 | 16 | 17 | 15 | 16 |
Dizziness | 1 | 3 | 5 | 15 | 7 | 21 | 13 | 14 | 13 | 14 |
Forgetfulness or confusion | 3 | 10 | 6 | 18 | 5 | 15 | 14 | 15 | 12 | 13 |
Nausea or vomiting | 8 | 28 | 8 | 24 | 9 | 27 | 25 | 26 | 12 | 13 |
Cold/flu symptoms | 4 | 14 | 8 | 24 | 7 | 21 | 19 | 20 | 0 | 0 |
Study Discontinuation
Efficacy Results
Mean Change per Week | Low-Dosage Quetiapine Versus Placebo | Moderate-Dosage Quetiapine Versus Placebo | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo | Low-Dosage Quetiapine (150 mg/day) | Moderate-Dosage Quetiapine (300 mg/day) | ||||||||||
Measure | Estimate | SE | Estimate | SE | Estimate | SE | d | SE | p | d | SE | p |
Zanarini scale | ||||||||||||
Total score | –0.75 | 0.15 | –1.22 | 0.15 | –0.99 | 0.16 | –0.79 | 0.36 | 0.031 | –0.41 | 0.36 | 0.265 |
Affective disturbance | –0.32 | 0.06 | –0.48 | 0.07 | –0.38 | 0.07 | –0.78 | 0.42 | 0.068 | –0.32 | 0.43 | 0.456 |
Cognitive disturbance | –0.21 | 0.04 | –0.34 | 0.04 | –0.30 | 0.04 | –0.63 | 0.28 | 0.023 | –0.43 | 0.28 | 0.127 |
Impulsivity | –0.09 | 0.03 | –0.14 | 0.03 | –0.13 | 0.03 | –0.37 | 0.26 | 0.156 | –0.30 | 0.27 | 0.269 |
Disturbed relationship | –0.18 | 0.05 | –0.32 | 0.05 | –0.27 | 0.05 | –0.75 | 0.38 | 0.051 | –0.48 | 0.38 | 0.204 |
Zanarini scale, self-rated | ||||||||||||
Total score | –0.58 | 0.18 | –1.29 | 0.18 | –1.28 | 0.19 | –0.88 | 0.32 | 0.006 | –0.87 | 0.32 | 0.007 |
Affective disturbance | –0.25 | 0.08 | –0.47 | 0.08 | –0.53 | 0.09 | –0.70 | 0.34 | 0.040 | –0.87 | 0.34 | 0.013 |
Cognitive disturbance | –0.15 | 0.06 | –0.34 | 0.06 | –0.35 | 0.06 | –0.71 | 0.29 | 0.016 | –0.73 | 0.29 | 0.013 |
Impulsivity | –0.10 | 0.04 | –0.17 | 0.04 | –0.16 | 0.04 | –0.39 | 0.30 | 0.191 | –0.35 | 0.29 | 0.232 |
Disturbed relationship | –0.14 | 0.05 | –0.36 | 0.05 | –0.32 | 0.05 | –0.86 | 0.27 | 0.002 | –0.73 | 0.27 | 0.008 |
Borderline Evaluation of Severity Over Time | ||||||||||||
Total score | –0.91 | 0.31 | –2.10 | 0.32 | –1.97 | 0.33 | –0.85 | 0.32 | 0.009 | –0.75 | 0.32 | 0.020 |
Thoughts and feelings | –0.46 | 0.20 | –1.29 | 0.20 | –1.21 | 0.21 | –0.90 | 0.31 | 0.004 | –0.82 | 0.31 | 0.009 |
Negative behaviors | –0.18 | 0.08 | –0.41 | 0.08 | –0.39 | 0.08 | –0.55 | 0.28 | 0.054 | –0.49 | 0.28 | 0.079 |
Positive behaviors | 0.25 | 0.08 | 0.42 | 0.08 | 0.35 | 0.09 | 0.52 | 0.35 | 0.146 | 0.30 | 0.36 | 0.407 |
Montgomery-Åsberg Depression Rating Scaleb | –0.59 | 0.18 | –0.85 | 0.19 | –1.05 | 0.19 | –0.31 | 0.32 | 0.328 | –0.56 | 0.32 | 0.083 |
Modified Overt Aggression Scaleb | –0.37 | 0.43 | –1.92 | 0.42 | –1.82 | 0.43 | –0.82 | 0.32 | 0.014 | –0.76 | 0.32 | 0.020 |
Young Mania Rating Scaleb | –0.11 | 0.06 | –0.26 | 0.06 | –0.30 | 0.06 | –0.40 | 0.21 | 0.060 | –0.50 | 0.21 | 0.019 |
Global Assessment of Functioning Scaleb | 0.62 | 0.19 | 1.05 | 0.20 | 1.04 | 0.21 | 0.49 | 0.33 | 0.135 | 0.49 | 0.33 | 0.141 |
Barratt Impulsiveness Scaleb | –0.59 | 0.26 | –0.73 | 0.27 | –0.83 | 0.27 | –0.08 | 0.21 | 0.719 | –0.13 | 0.21 | 0.536 |
Symptom Checklist–90–Revised | –0.07 | 0.02 | –0.11 | 0.02 | –0.12 | 0.02 | –0.47 | 0.28 | 0.099 | –0.62 | 0.29 | 0.033 |
Sheehan Disability Scaleb | ||||||||||||
Total score | –0.58 | 0.18 | –0.85 | 0.19 | –1.11 | 0.20 | –0.38 | 0.37 | 0.310 | –0.72 | 0.37 | 0.054 |
Work/school | –0.10 | 0.07 | –0.28 | 0.08 | –0.28 | 0.08 | –0.56 | 0.32 | 0.081 | –0.55 | 0.31 | 0.088 |
Social life | –0.22 | 0.08 | –0.27 | 0.09 | –0.36 | 0.09 | –0.17 | 0.40 | 0.679 | –0.46 | 0.40 | 0.255 |
Family life/home responsibilities | –0.25 | 0.07 | –0.31 | 0.08 | –0.45 | 0.08 | –0.19 | 0.36 | 0.591 | –0.66 | 0.36 | 0.073 |
Days lost | 0.05 | 0.11 | –0.33 | 0.12 | –0.36 | 0.12 | –0.49 | 0.21 | 0.025 | –0.54 | 0.21 | 0.012 |
Days unproductive | –0.33 | 0.21 | –0.58 | 0.23 | –0.88 | 0.23 | –0.26 | 0.32 | 0.424 | –0.55 | 0.31 | 0.086 |
Safety Results
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