Crnobaric 1998.
Methods | Randomised, double‐blind, placebo‐controlled, parallel study | |
Participants | Country: Yugoslavia Site: No details in abstract Recruitment: 25 women randomised. Age 18‐40 years (mean 29.5). See Table of bias for details of attrition Inclusion: Aged 18 to 40 with regular menstrual cycles. Meeting DSM‐IV criteria for PMDD Exclusion: Current history of major depressive disorder, current mental disorder |
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Interventions | Screening: Two cycle screening Placebo run in: None Interventions: Fluoxetine 20mg (n=14) versus placebo (n=11) taken daily Duration: Two cycles of treatment Timing of administration: No details as to when in the cycle medication was commenced Summary measures: No details as to whether the data was the mean of two treatment cycles or the last cycle data |
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Outcomes | Clinical Global Impression Scale (CGI); Hamilton Rating Scale of Depression (HAM‐D); Calendar of Premenstrual Experience (COPE) | |
Notes | No details of funding source | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States randomised. Method not reported |
Allocation concealment (selection bias) | Unclear risk | Method not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind, no further details |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 25 women randomised. No attrition |
Selective reporting (reporting bias) | Unclear risk | Three symptom scoring questionnaires used but results reported for only two |
Other bias | Unclear risk | Few details available as not published in full text |