Szegedi 1995.
Methods | Randomised, multicentre, parallel‐group, double‐ blind clinical trial in depressed out‐patients. | |
Participants | Age range: 18–71 years. Exclusion criteria were requirement of hospitalisation, presence of psychotic symptoms, acute risk of suicidality or severe existing physical disease, pregnancy or lactation, or the need of additional benzodiazepine treatment. |
|
Interventions | Paroxetine: 145 participants. Maprolitine: 153 participants. Paroxetine dose range: 20‐40 mg/day. Maprolitine dose range: 100‐150 mg/day. |
|
Outcomes | Hamilton rating scale for depression (HDRS), Clinical Global Impression (CGI), Montgomery and Asberg Depression Rating Scale (MADRS), Hamilton rating scale for anxiety (HAM‐A), Bech‐Rafaelsen Mania Scale (BRMS), Raskin Depression score (RDS), Covi Anxiety Score (CAS). | |
Notes | Funding: unclear. The study population includes subjects with diagnoses of major and minor depression. According to the protocol of this review, only data referring to patients with major depression were considered. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "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 (...) a double dummy design was used". No further details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blind (...) a double dummy design was used". No further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "for all patients receiving active medication an Intention‐to‐treat (ITT) analysis was performed using the Last Observation Carried Forward (LOCF) method". |
Selective reporting (reporting bias) | High risk | Only most often experienced adverse effects reported. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |