de Jonghe 2001.
| Methods | Single‐centre RCT with 2 parallel arms | |
| Participants | Consecutive newly registered psychiatric clinic outpatients Inclusion criteria: aged 18‐60 years, DSM‐III‐R major depression, HDRS baseline score of at least 14 points and informed consent Exclusion criteria: presence of psycho‐organic disorder, drug abuse, psychotic disorder, with or without dissociative disorder; communication barrier; participant was not considered 'reliable' enough to participate; participation was physically impossible; contraindication for 1 of the antidepressants in the trial; adequate pharmacotherapy treatment for the current major depressive episode; pregnancy 167 people were randomised to each arm, but 38 refused after randomisation. 129 participants started the trial |
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| Interventions | Intervention: combined treatment arm with psychotherapy and pharmacotherapy for 24 weeks. Psychotherapy was SPSP, based on Werman 1984 or de Jonghe 1994; 18 sessions of 45 min, the first 8 weekly and the last 8 biweekly, performed by 6 psychotherapists who were not the psychiatrists providing medication; all psychotherapists had at least 5 years of experience in psychoanalytic supportive therapy. The therapy was manualised (by the study authors) and there were weekly sessions to assess adherence to therapy. The pharmacotherapy was a stepwise approach in which participants where in the case of intolerance or inefficacy the treatment was changed from fluoxetine, to amitriptyline, then moclobemide Control: pharmacotherapy alone for 24 weeks |
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| Outcomes | Measures were the HDRS, the SCL‐90 Depression scale, the CGI Improvement and Severity scales, and the QLDS. These were measured at pre‐ and post‐treatment. Remission rates were also measured at 8, 16 and 24 weeks. The study used ITT data (including participants who refused treatment after randomisation), completers only data, and a per‐protocol set (all participants who started with the treatment to which they were allocated) | |
| Notes | HDRS Depression score and QLDS data used in short‐term measures of ITT sample. CGI‐Severity data only available for per‐protocol sample and risk of attrition bias noted | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: insufficient information |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information |
| Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "Patients and treating physicians were not masked to randomisation, the raters were not informed about the treatment condition and were instructed to restrict themselves to discussion of the HRSD items" Comment: the use of independent raters to rate depression (HSRD) minimises a risk of detection bias ‐ low risk. However, physician rated psychiatric symptoms (CGI‐S) scores bring a high risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: ITT analyses conducted and ITT data used in analyses of depression and social adjustment, thus minimising the risk of attrition bias. Per‐protocol data used for examining CGI, therefore, high risk of bias |
| Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to permit judgement. No published report on pre‐specified outcomes |
| Other bias | Unclear risk | Comment: insufficient information to permit judgement |