AstraZeneca 2007.
Study characteristics | ||
Methods | 8‐week trial with 2 arms:
Duration of trial: 8 weeks + 10 weeks follow‐up Country: The Netherlands Setting: no information |
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Participants |
Methods of recruitment of patients: no information Overall sample size: 24 Diagnosis of borderline personality disorder: DSM‐IV Means of assessment: SCID‐II Mean age: no information Sex: no information Comorbidity: no information Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group
Treatment name: quetiapine fumarate
Number randomised to group: 13
Duration: 8 weeks Control/comparison group Comparison name: placebo Number randomised to group: 11 Duration: 8 weeks Both groups Concomitant psychotherapy: no information Concomitant pharmacotherapy: not allowed, except for SSRIs and benzodiazepines, with doses stabilised 8 weeks before start of trial period Proportions of participants taking standing medication during trial observation period: no information |
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Outcomes |
Primary outcomes: none Secondary outcomes
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Notes |
Sample size calculation: no information Ethic approval: no information Funding source: funded or partially funded by pharmaceutical industry Conflicts of interest: The trial director is affiliated with AstraZeneca who produces the medication tested. Comments from review authors (limitations)
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no information |
Allocation concealment (selection bias) | Unclear risk | Comment: no information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Trial registration stated that the study had triple blinding (participant, care provider and investigator), however, there was no information on how the blinding was secured or if it was adequately maintained throughout the study to permit a judgement of low or high risk of bias. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Trial registration stated that the study had triple blinding (participant, care provider and investigator), however, there was no information on how the blinding was secured or if it was adequately maintained throughout the study to permit a judgement of low or high risk of bias. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: dropout 5/13 in experimental intervention and 3/11 in placebo group. No information on reasons for dropout or imputation method |
Selective reporting (reporting bias) | High risk | Comment: The protocol mentioned psychotic‐like symptoms and severity of psychiatric symptoms + mood, anger, impulsiveness, hostility and anxiety in patients with BPD. Only psychotic and dissociative symptoms were reported. |
Vested Interest (funding and/or author affiliations) | High risk | Comment: Trial director is from AstraZeneca and the medication tested is from AstraZeneca. |
Other bias | Low risk | Comment: no indication of other bias |