Shafti 2010.
Study characteristics | ||
Methods | 8‐week trial with 2 arms:
Duration of trial: 8 weeks Country: Iran Setting: inpatient |
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Participants |
Method of recruitment of participants: The participants were inpatients. Not otherwise specified Overall sample size: 28 Diagnosis of borderline personality disorder: DSM‐IV Means of assessment: no information Mean age: 29.49 years (SD = no information; range = no information) Sex: 100% women Comorbidity: none Inclusion criteria: female gender Exclusion criteria: any prominent comorbid mental disorder |
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Interventions |
Experimental group
Treatment name: olanzapine
Number randomised to group: 14
Duration: 8 weeks Control/comparison group Comparison name: haloperidol Number randomised to group: 14 Duration: 8 weeks Both groups Concomitant psychotherapy: not allowed Concomitant pharmacotherapy: not allowed Proportions of participants taking standing medication during trial observation period: no other concurrent psychotropic medication during testing |
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Outcomes |
Primary outcomes: mental health status (functioning), measured by CGI‐S and BPRS. Assessed at baseline and at week 8 (EOT) Secondary outcomes
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Notes |
Sample calculation: yes Ethics approval: yes Funding source: no funding received Conflicts of interest: No conflicts of interest were reported. Comments from trial authors (limitations): "Small size of the samples, short duration of the trial, and sex‐based sampling were among the weaknesses of this trial". (Shafti 2010, p. 46) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: No information on method for random sequence generation to permit a judgement of low or high risk of bias |
Allocation concealment (selection bias) | Unclear risk | Comment: Insufficient information on concealment of random sequence allocation to permit a judgement of low or high risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: The article referred to the trial being double‐blind, however, there was insufficient information on how blinding of participants and personnel was carried out and maintained to permit a judgement of low or high risk of bias. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: The article referred to the trial being double‐blind, however, there was insufficient information on how blinding of outcome assessors was carried out and maintained to permit a judgement of low or high risk of bias. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: No attrition |
Selective reporting (reporting bias) | Unclear risk | Comment: No protocol found |
Vested Interest (funding and/or author affiliations) | Low risk | Comment: No conflicts of interest reported |
Other bias | Low risk | Comment: No other sources found |