Serotonin and norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors and other antidepressants and persistent sexual dysfunction - An EudraVigilance analysis

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Case series review of Pharmacovigilance data
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CITALOPRAM

  FLUOXETINE

  FLUVOXAMINE

  PAROXETINE

  PAROXETINE ACETATE

  SERTRALINE

  DESVENLAFAXINE

  FLUOXETINE HYDROCHLORIDE

  PHENTERMINE HYDROCHLORIDE

  OLANZAPINE
• Medical condition to be studied:
  Loss of libido

  Genital hypoaesthesia

  Libido decreased

  Female sexual arousal disorder

  Anorgasmia

  Female orgasmic disorder

  Male orgasmic disorder
• Additional medical condition(s):
  Post-SSRI Sexual Dysfunctions

Population studied

• Short description of the study population:
  Case reports of persistent sexual dysfunctions to Serotonin and norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors and other antidepressants.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Estimated number of subjects:
  3210

Study design details

• Main study objective:
  Describe cases of Post-SSRI sexual dysfunction
• Data analysis plan:
  Descriptive statistics were run on the totality of the cases with sexual dysfunctions, by reporter type, by substance, by class, by indication, by country, by age, gender and by previous medical history of sexual dysfunction. Results by reaction were stratified by core PSSD case definition (see 4.3.2.), extended terms definition, which are the remaining terms from the sexual dysfunction case definition (see 4.3.1.) and secondary terms as per annex II.

Documents

Study results

Antidepressants and PSSD - EV analysis - report - 20190220