Lydiard 1997.
| Methods | 8‐week, double‐blind, randomised, multi‐centre study, placebo wash‐out with elimination of placebo responder | |
| Participants | Psychiatric outpatients meeting DSM‐III‐R criteria for major depression, having a minimum score of 18 on the 17‐item HAM‐D Age: AMI mean 39.0 years; PBO mean 40.2 years Sex: AMI M41, F90; PBO M43, F86 Exclusion criteria: 17‐item HAM‐D < 18, improvement during placebo wash‐out, acute or chronic organic mental disorder, obsessive compulsive disorder, post‐traumatic stress disorder, schizophrenia, paranoid disorders, psychotic disorders not elsewhere classified, severe personality disorder, significant medical illness, recent history of substance abuse or dependence, current suicide risk, history of neurologic disease, narrow‐angle glaucoma, significant prostate syndromes, requirement of additional psychotropic drugs, received sertraline, recent participation in investigational drug study, no response to adequate trials of antidepressants, depot during past 6 months, fluoxetine within 1 month, daily psychotropic medication within 2 weeks, MAO‐I within 3 weeks, significant ECG or laboratory abnormalities, pregnancy or unreliable contraception |
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| Interventions | Amitriptyline: 131 participants Placebo: 129 participants Amitriptyline dose: range 50 mg to 150 mg, mean final dose 103.1 mg |
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| Outcomes | Primary outcome: 17‐item HAM‐D, CGI Secondary outcome: MADRS, CGI‐Improvment, CGI‐Severity, GAS, Quality of Life Enjoyment and Satisfaction Questionnaire, HRQOL‐II, POMS, BDI |
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| Notes | Sponsor: Pfizer Inc. Response: CGI ≤ 2 Remission: no definition, no data 3‐arm study comparing sertraline to amitriptyline and placebo (total 392 participants) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly assigned", no further details |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Medication provided as identical capsules in blister pack format and was administered orally" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Medication provided as identical capsules in blister pack format and was administered orally" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Medication provided as identical capsules in blister pack format and was administered orally", no details on blinding of assessor |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All drop‐out reasons reported, different numbers for amitriptyline and placebo drop‐outs due to side effects (17.6% and 5.3%, respectively), ITT analysis (at least 1 dose and 1 post baseline rating), last observation carried forward |
| Selective reporting (reporting bias) | High risk | Results for MADRS, social adjustment and health‐related quality of life not reported (only P values) |
| Other bias | Low risk | No clear other bias |