Peselow 1989.
Methods | Six‐week, single‐centre, double‐blind, randomised, parallel‐group study. | |
Participants | Only moderate to moderately severe depressed patients with a DSM‐III diagnosis of major depressive disorder without mania, characterised by disorder of mood with symptoms such as depressed mood, sadness, hopelessness, and worthlessness‐were to be admitted to the study. In addition to the DSM‐III diagnostic criteria, the participant had to: (1) be al least 18 years old and (2) have Hamilton rating scale for depression (HDRS‐21) score at the screen and baseline visits of at least 18 on the first 17 items of the 21‐item scale, and the HDRS‐21 total could not decrease by 20% or more between the screen and baseline visits, and (3) have a Raskin Depression Scale (RDS) score at baseline of at least 8, and the RDS score had to be higher than the Covi Anxiety Scale score (CAS). | |
Interventions | Paroxetine: 40 participants. Imipramine: 39 participants. Paroxetine dose: 20‐50 mg/day. Imipramine dose: 65‐275 mg/day. |
|
Outcomes | HDRS‐21, RDS, Clinical Global Impression (CGI) Severity, Improvement, Patients Global Evaluation (PGE). Total dropout, dropout due to side‐effects, dropout due to inefficacy. Number of patients experiencing at least one side effect, side‐effect profile. | |
Notes | Funding: unclear. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomized". No further details. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blind (...) the subject received two medication bottles and was instructed to take two capsules from the bottle labeled "morning" and one capsule from the bottle labeled "evening". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blind". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "the primary analysis of the study is based on the wee 6 evaluation from the All Efficacy Population using a Last Observation Carried Forward (LOCF) approach". More than 20% of participants in the paroxetine arm withdrew from the study prematurely. |
Selective reporting (reporting bias) | High risk | Only most frequent adverse effects were reported. |
Other bias | Unclear risk | Insufficient information to establish the presence of other biases. |