Jariani 2010.
Study characteristics | ||
Methods | 12‐week trial with 2 arms:
Duration of trial: 12 weeks Country: Iran Setting: outpatient |
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Participants |
Methods of recruitment of patients: no information other than patients on methadone maintenance treatment with BPD diagnosis Overall sample size: 120 Diagnosis of borderline personality disorder: DSM‐IV‐TR Means of assessment: clinical interview Mean age: 27 years (SD = no information; range = no information) Sex: no information on percentage for overall sample size Comorbidity: 100% had a substance use disorder. Inclusion criteria: no information Exclusion criteria: no information; however, stated that patients did not suffer from any axis I disorders or other somatic disorders such as hepatitis or AIDS |
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Interventions |
Experimental group
Treatment name: olanzapine (5‐10 mg/d, exact mean final dose unclear)
Number randomised to group: no information*
Duration: 12 weeks Control/comparison group Comparison name: sertraline (50‐100 mg/d, exact mean final dose unclear) Number randomised to group: no information* Duration: 12 weeks Both groups Concomitant psychotherapy: no information Concomitant pharmacotherapy: methadone Proportions of participants taking standing medication during trial observation period: 100% of participants were concomitantly treated with methadone. |
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Outcomes |
Primary outcomes
Secondary outcomes
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Notes |
Sample calculation: yes Ethics approval: yes, "This clinical trial was granted an approval from Medical Ethics Committee at Lorestan Medical University on 12/04/2007". (Jariani 2010, p. 545) Funding source: unclear funding Conflicts of interest: No conflicts of interest were reported. Comments from trial authors (limitations): none mentioned Comments from review authors: *No information provided for the number of participants in each group and not possible to contact the authors |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: According to the sample size formula, 120 males and females on MMT with a diagnosis of BPD were chosen and randomly placed in two groups in which they received either olanzapine (5‐10 mg daily) or sertraline (50‐100 mg daily) (Jariani 2010, p. 545). |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on allocation concealment reported to permit a judgement of low or high risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: no information on blinding reported to permit a judgement of low or high risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information on blinding reported to permit a judgement of low or high risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: The complete numbers of participants in each group were not provided for analysis results. No details given about patient flow after randomisation |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found |
Vested Interest (funding and/or author affiliations) | Unclear risk | Comment: no information |
Other bias | Low risk | Comment: no other sources found |