Appleby 1997.
| Study characteristics | ||
| Methods |
Study design: RCT, double‐blind Location: UK (Manchester) Setting: community setting No. of centres: 2 large hospitals in an urban health district Dates of study: recruitment May 1993‐February 1995 Total duration of study: 23 months; recruitment (20 months), follow‐up (12 weeks) Recruitment: women on maternity wards were asked to allow assessment of their mood in their homes 6‐8 weeks later 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 |
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): fluoxetine + 1 counselling session N = 22; fluoxetine + 6 counselling sessions N = 21; placebo + 1 counselling session N = 23; placebo + 6 counselling sessions N = 21 Age (mean) years: fluoxetine + 1 counselling session 25.7; fluoxetine + 6 counselling sessions 26.6; placebo + 1 counselling session 23.1; placebo + 6 counselling sessions 26.0 Severity of PND, mean (range) score: CIS‐R: fluoxetine 28.2 (26.4‐30.1); placebo 28.3 (26.6‐30.1), EPDS: fluoxetine 17.2 (16.2‐18.2); placebo 16.9 (15.8‐18.1), HAM‐D: fluoxetine 13.2 (13‐15.5); placebo 13.9 (12.5‐15.4) Duration of PND: not reported Physical health co‐morbidities: not reported Mental health co‐morbidities: not reported 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 |
Primary outcome: depressive symptoms as measured by mean scores on the CIS‐R, the HAM‐D (week 1 and 12 only) and EPDS Time points: week 1, 4 and 12 |
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| Notes | Funding source not given | |
| 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 of participants (performance bias) | 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 of personnel (performance bias) | 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 of outcome assessment (detection bias) All outcomes | 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 dropouts 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 No funding details reported |