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. 2022 Nov 14;2022(11):CD012956. doi: 10.1002/14651858.CD012956.pub2

AstraZeneca 2007.

Study characteristics
Methods 8‐week trial with 2 arms:
  1. quetiapine fumarate

  2. placebo


Duration of trial: 8 weeks + 10 weeks follow‐up
Country: The Netherlands
Setting: no information
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
  1. BPD according to DSM‐IV, including criterion 9: transient, stress‐related paranoid ideation or severe dissociative symptoms

  2. Aged 18‐55 years

  3. In‐ or outpatients


Exclusion criteria
  1. Depressive disorder

  2. Bipolar disorder

  3. Schizoaffective disorder/schizophrenia/delusional disorder/schizotypal personality disorder

  4. Alcohol or substance dependence

  5. quetiapine doses > 100 mg od use in the past

  6. History of trauma capitis

  7. Visual and auditive disorders

  8. Neurological disorders (epilepsy)

  9. Pregnancy

  10. No adequate contraception

  11. History of cardial complaints/cardiological disorder

  12. Known sensitivity for quetiapine

Interventions Experimental groupTreatment name: quetiapine fumarate
Number randomised to group: 13
Duration: 8 weeks
Control/comparison groupComparison name: placebo
Number randomised to group: 11
Duration: 8 weeks
Both groupsConcomitant 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
Outcomes Primary outcomes: none
Secondary outcomes
  1. Dissociation and psychotic‐like symptoms, measured by the BPRS, PANSS and the Dissociation Questionnaire (DIS‐Q). Assessed at baseline and at 1, 2, 4, 6 and 8 weeks

  2. Attrition, measured in terms of patients lost after randomisation in each group

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)
  1. Small sample, underpowered

  2. Key trial dates are a considerable duration of time apart

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