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. 2021 May 5;2021(5):CD013491. doi: 10.1002/14651858.CD013491.pub2

Berlanga 1999.

Study characteristics
Study details Sponsorship source: Not reported
Country: Mexico
Setting: Secondary care (outpatients)
Year of recruitment: 1994 ‐ 1996
Author's contact details: Mexican Institute of Psychiatry, Avenue México‐Xochimilco 101 Colonia San Lorenzo Huipulco, Tlalpan, Mexico D.F. 14370 (e‐mail: cisnerb@lmp.edu.mx)
Methods Type of study: Model development study
Source of data: Post‐RCT* prospective follow‐up study
Method used for model development: Logistic regression (multivariable analysis with a stepwise backward method in which variables that were significant in the univariable analysis were introduced into the model)
Method used for internal validation: Not reported
External validation: Not done
Handling of missing data: Not reported
Evaluation of clinical utility: Not assessed
Sample size Total number of participants (Number with event): 42 (18)
Number of candidate predictor parameters: Not reported
Number of predictors in final model: 3
Number of events per candidate predictor parameter (EPP): Unclear
Population Inclusion criteria:
  • Between 18 and 65 years old

  • DSM‐IV criteria for diagnosis of major depressive disorder

  • Scoring at least 18 points on the first 17 items of the 21‐item version of the Hamilton Rating Scale for Depression (HAM‐D)


Exclusion criteria:
  • Psychotic symptoms

  • Substantial suicide risk

  • If any other situation required hospitalisation

Baseline characteristics Mean age (SD): Recurrence group: 34.8 (11.1); No‐recurrence group: 37.2 (11.2)
Gender (% Female): Recurrence group: 83; No‐recurrence group: 71
Start‐point (diagnosis of depression and remission) Depression: Major depressive disorder according to DSM‐IV criteria and at least 18 points on the first 17 items of the 21‐item HAM‐D
Remission: Definition of remission not reported
End‐point (diagnosis of relapse/recurrence) Recurrence: Fulfilling criteria for MDD (clinical interview) per Frank 1991
Timing (length of follow‐up) 12 months
Notes *The RCT compared the clinical efficacy and tolerance of the antidepressants nefazodone and fluoxetine. A 'washout period' of at least 3 weeks free of antidepressant medication was a requisite for all participants