Bloch 2012.
| Study characteristics | ||
| Methods |
Study design: RCT, double‐blind, placebo‐controlled Location: Israel Setting: maternity ward and baby care centre No. of centres: 1 (Tel Aviv Sourasky Medical Center) Dates of study: not reported Total duration of study: 8 weeks Recruitment: patients were referred from maternity wards or from baby care centres Randomisation method: pharmacy‐generated random serial numbers Analysis by ITT: yes (LOCF) Power calculation: yes |
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| Participants |
Inclusion criteria: aged 18‐45 years; met criteria for current MDD during screening and baseline visit according to DSM‐IV (Structured Clinical Interview for DSM‐IV Axis I disorders), onset of depression within 2 months of delivery Exclusion criteria: MADRS score ≥ 30, suicidal ideation (MADRS item 10 score ≥ 5), psychotic symptoms or bipolar disorder, current depressive episode > 6 months, current treatment with antidepressants, 2 failed adequate trials of antidepressants, major physical illness, alcoholism or drug use Number recruited: 42 Number dropped after baseline assessment: 2 (both from placebo + BDP* group) Number dropped out by week 8: 4 from sertraline + BDP group; 3 from placebo + BDP group (not including the 2 dropped out after baseline assessment) Number analysed: 40 (2 participants who dropped out after baseline excluded): sertraline N = 20; placebo N = 20 Age: no data Severity of PND mean (SD) score: MADRS: sertraline 19.8 (4.98); placebo 19.8 (4.64) EPDS: sertraline 18.4 (4.83); placebo 16.05 (4.84) CGI‐S: sertraline 3.7 (0.66); placebo 3.8 (0.62) CGI‐I: sertraline 2.65 (1.18); placebo 2.45 (1.10) MHI‐wellbeing: sertraline 2.08 (0.74); placebo 2.01 (0.64) MHI‐distress: sertraline 4.16 (0.77); placebo 3.83 (0.86) Duration of PND: not reported Physical health co‐morbidities: not reported Mental health co‐morbidities: anxiety diagnosis: sertraline N = 5; placebo N = 4, past depression: sertraline N = 4; placebo N = 5 Ethnicity: no data Socioeconomic status: sertraline + BDP group: high income: 7/20 (35%), middle income: 10/20 (50%), low income: 3/20 (15%); placebo + BDP group: high income: 4/20 (20%), middle income: 7/20 (35%), low income 9/20 (45%) |
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| Interventions | Women were randomly assigned to 1 of 2 groups
*BDP is a time‐limited psychotherapeutic intervention that aims to enhance the patient's insights about repetitive circumstances. |
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| Outcomes |
Primary outcome: continuous change in depressive symptoms as measured by the MADRS and EPDS during 8‐week randomisation phase Secondary outcomes: continuous change in MADRS and EPDS during open phase of the study (weeks 8‐12), proportion of women meeting response and remission status at week 8 (response defined as > 50% reduction in MADRS or EPDS scores during treatment and remission as a final score of < 10 on the MADRS or < 7 on the EPDS) Other secondary ratings: measurements of symptom severity using the CGI‐I and CGI‐S, assessment of global mental health with the MHI and assessment of adverse effects using the UKU Side Effect Rating Scale Time points: weeks 0, 2, 4, 6, 8, 12 |
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| Notes | This study was funded by an Independent Investigator Award to Dr Bloch from the National Alliance for Research on Schizophrenia and Depression, Great Neck, New York. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The institution's pharmacy‐generated random patient serial numbers with active versus placebo ratio 1:1 were issued to the researchers and randomly assigned to eligible patients by the psychiatrist after the informed consent was signed". |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information given to be certain of allocation concealment |
| Blinding of participants (performance bias) | Low risk | "The second group received dummy pills daily, identical in appearance to the active pills, according to the same protocol as the active group" |
| Blinding of personnel (performance bias) | Low risk | "The managing psychiatrist was blinded to treatment condition... The managing psychiatrist was also asked at the end of the full protocol to document her assessment of whether the patient received active or placebo pills, and indeed, was unable to correctly guess this factor in every instance" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details given on who assessed outcomes so unclear whether outcome assessors were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Seven patients discontinued medication between weeks 4 and 8, three from the placebo group and four from the active group. Discontinuation was due to lack of motivation (n = 4: placebo group, n = 2; sertraline group, n = 2) and clinical deterioration (n = 3: placebo group, n = 1; sertraline group, n = 2)." 42 participants were originally in the study, 2 participants dropped out of the placebo group immediately after the baseline. 40 participants are included in the ITT |
| Selective reporting (reporting bias) | Unclear risk | Insufficient detail in protocol |
| Other bias | Unclear risk | "A pill count was conducted to monitor compliance. Protocol violation was defined as <80% compliance by pill count" It is unclear whether the 7 patients who discontinued medication are the only participants with low compliance "The compliance for psychotherapy was good: in the sertraline group, 92% of the psychotherapy sessions were attended compared to 87% in the placebo group (P = NS) [not significant]" |