Phillips 2002.
| Methods | DESIGN
Description: Randomized, placebo‐controlled, parallel, flexible dose, 1 week single blind placebo run‐in BLINDING Participants: Unclear Assessors: Yes Administrators: Yes ALLOCATION CONCEALMENT Method: clinician kept code RANDOMISATION Method: computer generated urn procedure |
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| Participants | SAMPLE
Description: 67 DSM‐IV BDD, 68.7% female, average age: 32.1 years, average duration of illness: 14.5 years, 64.2% MDD, baseline severity on BDD‐YBOCS: 31.5 (fluoxetine) 30.8 (placebo) SCREENING Primary diagnosis: BDD‐DM Comorbidity: SCID‐P; SCID‐PD |
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| Interventions | Description: fluoxetine (20‐80mg/d; mean dose: 77.7 mg/d) vs placebo (20‐80mg/d; mean dose: 76 mg/d) x 12 weeks | |
| Outcomes | Primary outcomes: BDD‐YBOCS,
Secondary outcomes: CGI‐I, BDD‐CGI, BDD‐NIMH,BABS, HAM‐D, BPRS, SOFAS, GAF Data estimation: LOCF |
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| Notes | INDUSTRY SUPPORT
Industry funded: No
Medication provided by industry: Yes
Any of the authors work for industry: Yes ADDITIONAL INFORMATION Drop‐out rates: 0 on fluoxetine and placebo Quality rating score: 39 3 patients in the fluoxetine and placebo groups received ongoing psychotherapy (not CBT) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | A ‐ Adequate |