Trittico Prolong 300 mg in the treatment of depression

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional post-authorization safety study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06AX05) trazodone

  trazodone
• Medical condition to be studied:
  Major depression

Population studied

• Short description of the study population:
  Depressive patients aged 18 years or older of different etiology, including those associated with anxiety, sleep disorders or sexual dysfunctions of inorganic origin. The population included both hospitalized and outpatients.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Major depression patients
• Estimated number of subjects:
  85

Study design details

• Main study objective:
  The non-interventional questionnaire study aim was to investigate the safety and efficacy of Trittico Prolong 150 mg and Trittico Prolong 300 mg tablets in the treatment of moderate (MADRS score 21-25) to severe (MADRS scores ≥ 26) depression with single dose of 300 mg trazodone in common clinical practice.
• Outcomes:
  MADRS, CGI/S, CGI/I scores, nature, frequency and intensity of the adverse drug reactions.
• Data analysis plan:
  Standard descriptive statistics (Wilcoxon test, McNemar test)

Documents

Study results

Trittico Prolong_final report_SUKL

Study publications

Češková E, Šedová M, Kellnerová R, Starobová O. Once-a-day trazodone in the tre…