Reist 1989.
Study characteristics | ||
Methods | Design: multi‐centre trial, randomised, placebo‐controlled, flexible‐dose, double‐blind, 4 day switched cross‐over Duration of intervention: 8 weeks Placebo run‐in: 1 week Post‐treatment: Not specified |
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Participants | Setting: USA (outpatient psychiatry service and local Vietnam veterans outreach centers) Sample size: 27 randomised to desipramine and placebo Mean age: 38.4 years (28 ‐ 64) Sex: 27 men, combat veterans, 33% (6/18) major depression, most prevalent comorbidity: 50% (9/18) dysthymic disorder Diagnostic measure: DSM‐III Inclusion criteria: Quote: “The patient sample originally comprised of 27 hospitalised men aged 28‐64 years who were diagnosed as having PTSD according to DSM‐III criteria" Exclusion criteria: medication, drugs and alcohol Comorbidity: SCID, SCID ‐ DSM‐III‐R for personality disorders: MD, dysthymic disorder Dropout rates: 33% (9/27). There was insufficient information to determine dropouts by group separately |
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Interventions | Pharmacological intervention: Quote: “Patients were treated with oral desipramine at the beginning dose of 50 mg/day. This was increased daily by 50‐mg increments to a maximum dose of 200 mg/day" | |
Outcomes | Outcomes: HAM‐D, HAM‐A, BDI, IES (no distinction between primary and secondary outcomes) Time points: Not specified Data estimation: Completer values |
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Notes | Dates of trial: Quote: “Between September 1986 and February 1987” Industry‐funded: No information Medication provided by industry: Unclear Any of the authors work for industry: No |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It was reported that the participants were randomised, but no mention is made of the method of randomisation Quote: "Following this workup during the first week of hospitalisation, patients were randomly assigned to treatment with desipramine or placebo (double‐blind)" |
Allocation concealment (selection bias) | Unclear risk | There was insufficient information provided to determine if study medication allocation was concealed |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The study was described as "double‐blind", although no information was provided on which parties were blinded and how blinding was achieved Quote: "Following this workup during the first week of hospitalisation, patients were randomly assigned to treatment with desipramine or placebo (double‐blind)" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The study was described as "double‐blind", although no information was provided on blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There was insufficient information to determine dropouts by group separately. Thirty‐three percent of the patients across both groups withdrew from the trial. No information was provided on whether the two groups differed by sample characteristics at baseline and endpoint. Completer values were used in the analysis Quote: "Of the original patients, 21 completed the cross‐over period. Six patients dropped out for the following reasons: one patient left the hospital against medical advice; one patient was excluded from continued substance abuse; two patients developed irritability and dysphoria while taking desipramine, and, during the workup period, one patient developed mania and one became intolerant of the ward structure and asked to be withdrawn" |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not available for this study |
Other bias | Unclear risk | No other sources of bias were identified except for ongoing recreational and group therapies |