Appleby 1997.
| Methods | Randomisation method: computer‐generated random numbers Analysis by ITT: yes (LOCF), in addition to analysis by completion Power calculation: none stated |
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| Participants | Setting: community‐based: women on maternity wards were asked to allow assessment of their mood in their homes 6‐8 weeks later Country: UK Inclusion criteria: women who scored ≥ 10 on the EPDS at the screening visit were assessed with the CIS‐R and eligible to participate if they scored ≥ 12, as well as satisfying research diagnostic criteria for major or minor depressive disorder Exclusion criteria: chronic (> 2 years) or resistant depression, current drug or alcohol misuse, severe illness requiring close monitoring or hospital admission, breastfeeding Number recruited: 87 Number dropped out: 26 Number analysed: 87 (additional completers analysis with 61 participants) Age (mean): fluoxetine + 1 counselling session 25.7 years; fluoxetine + 6 counselling sessions 26.6 years; placebo + 1 counselling session 23.1 years; placebo + 6 counselling sessions 26.0 years Ethnicity: no details Socioeconomic status: no details |
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| Interventions | Women were randomly assigned to 1 of 4 groups:
Counselling was derived from CBT and structured to offer reassurance and practical advice on areas of concern to depressed mothers |
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| Outcomes | Assessments were carried out at week 1, 4 and 12 Outcome was effect on depressive symptoms as measured by mean scores on the CIS‐R, the HAM‐D (week 1 and 12 only) and the EPDS |
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| Notes | Funding source not given. See footnote for abbreviations and description of outcome measures. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Subjects were allocated to one of four treatment groups by using computer generated random numbers" |
| Allocation concealment (selection bias) | Unclear risk | No details on allocation concealment given |
| Blinding (performance bias and detection bias) of participants | Low risk | "The counselling was delivered by a psychologist… supervised by a second psychiatrist, both were blind to drug treatment, as were trial subjects" |
| Blinding (performance bias and detection bias) of personnel | Low risk | "The counselling was delivered by a psychologist… supervised by a second psychiatrist, both were blind to drug treatment, as were trial subjects" |
| Blinding (performance bias and detection bias) of outcome assessors | Low risk | "The assessment interviews were conducted by a psychiatrist blind to subject treatment group" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "Drop‐out rates were similar in the four groups. Drop outs were younger than subjects who completed the study and more likely to have an unemployed partner and to have a planned pregnancy, but the groups did not differ on initial psychiatric morbidity scores, employment, obstetric complications, parity, family history, or personal history of depression, including postnatal depression" Of 87 total participants, 14/43 from the fluoxetine plus counselling group dropped out and 12/44 of the placebo plus counselling group dropped out Details of dropout timings and reasons were reported, but mainly "no reason given". Lack of improvement was the reason for 3 drop‐outs in the fluoxetine group but 0 in the placebo group. In contrast, 3 women in the placebo group but only 1 woman in the intervention group dropped out due to side effects |
| Selective reporting (reporting bias) | Unclear risk | Protocol unavailable |
| Other bias | Unclear risk | No details given on adherence to medication See footnote for abbreviations and description of outcome measures |