Cutting the First Turf to Heal Post-SSRI Sexual Dysfunction: A Male Retrospective Cohort Study
Rosaria De Luca; Mirjam Bonanno; Alfredo Manuli; Rocco Salvatore Calabrò
Medicines2022
In plain terms
Doctors at one clinic in Italy looked back at the records of 13 young men diagnosed with lasting sexual problems after taking an SSRI antidepressant. Each man was given a treatment chosen for him, most often another antidepressant called vortioxetine. On a questionnaire about erections and sexual function, scored from 0 to 30, the group's average rose from about 7, in the "severe" range, to about 18, in the "mild" range, after a year. Eleven of the 13 men scored higher; two did not change.
What it doesn’t show: It can't show that any of the treatments worked: there was no comparison group, each man got a different mix of treatments, and the men's problems might have changed over a year anyway.
Summary (paraphrased)
Thirteen men with PSSD after citalopram, paroxetine, sertraline, fluoxetine, or escitalopram were followed retrospectively after receiving varied individualized treatments, most commonly vortioxetine (alone in five men, with turmeric or nutraceuticals in one each); the other six received bupropion, tadalafil, or nutraceuticals, alone or combined, or pelvic muscle vibration. Erectile-function scores improved significantly in most patients; two did not respond. Onset timing varied — some patients developed enduring dysfunction within weeks of starting the SSRI, others only after stopping it. The authors present this as an early proof-of-concept that active treatment, particularly vortioxetine-based strategies, may help some PSSD patients.
Evidence
Extracted from the full text; page numbers refer to the paper. The library’s own notes are labelled as such.
- Design
- Case seriesRetrospective, uncontrolled before-and-after review of men treated for PSSD at one clinic (the authors call it a retrospective cohort study)
- Setting
- Neurobehavioural outpatient clinic, IRCCS Centro Neurolesi "Bonino-Pulejo", Messina, Italy; January 2020 to December 2021
- Population
- Men diagnosed with PSSD using published criteria (Healy et al. 2022; necessary criteria were prior serotonin reuptake inhibitor treatment and an enduring change in genital sensation after stopping), referred by doctors or self-referred via internet and media. Major depression, bipolar disorder and psychosis were excluded beforehand; the final sample had anxiety and/or adjustment disorders. Mean age 29.53 ± 4.57 years; all Caucasian.
- Size
- 13 · 13 men included of 30 referred to the clinic
- Exposure
- Treatment chosen for each man: vortioxetine alone (5 men; listed as 10 mg); vortioxetine 20 mg with turmeric (1); vortioxetine 15 mg with nutraceuticals (1); bupropion 300 mg (1); bupropion 150 mg, tadalafil 10 mg and nutraceuticals (1); nutraceuticals with bupropion 150 mg (1); nutraceuticals alone (1); tadalafil 10 mg (1); pelvic muscle vibration (Vibra-Plus) (1).
- Compared with
- None; each man's own baseline score
- Outcome
- International Index of Erectile Function-15 (IIEF-15) score at baseline (T0) and after 12 months (T1). The paper gives a 0–30 range with severity bands (1–10 severe, 11–16 moderate, 17–25 mild, 26–30 no ED). "Percentage of therapeutic success" is not defined; in every row it equals the score change divided by 30.
- Follow-up
- 12 months
Key results
- Mean IIEF-15 score 7.3 (SD 1.84; median 7) at baseline and 17.7 (SD 6.01; median 19) at 12 months; p = 0.003 (Wilcoxon signed-rank). Recomputed from the per-patient scores in Table 3, the means are 7.31 and 17.69, matching · p. 5, Table 3
- 11 of 13 men scored higher at 12 months; two were unchanged (vortioxetine 15 mg with nutraceuticals, 11 to 11; bupropion, tadalafil and nutraceuticals, 5 to 5). The text's "10/12" counts the 12 drug-treated men · pp. 4–5, Table 3
- Vortioxetine alone (5 men): from 5–8 (severe) at baseline to 15–25 at 12 months (four mild, one moderate); "therapeutic success" 33.3% to 60%. Vortioxetine with turmeric, 7 to 16 (30%) · p. 5, Table 3
- Single men on other treatments: bupropion 300 mg, 9 to 12 (10%); nutraceuticals with bupropion, 6 to 19 (43.33%); nutraceuticals alone, 6 to 15 (30%); tadalafil, 8 to 20 (40%); pelvic muscle vibration after no response to earlier drug treatment, 10 to 25 (50%) · p. 5, Table 3; p. 7
- The enduring sexual effects began 2–4 weeks after starting the SSRI in 8 men and 2–4 weeks after stopping it in 5. The SSRI had been taken for 1–48 months (citalopram, paroxetine, sertraline and escitalopram 3 men each; fluoxetine 1) · p. 4, Tables 1–2
Limitations the authors note
- The retrospective design prevented any a priori hypothesis
- Small sample size
- Only a baseline Hamilton depression score; repeated depression and anxiety measures (PHQ-9, GAD-7) would have been more helpful
- Not possible to compare the efficacy of the different compounds, alone or combined
- No pharmacogenetic assessment (e.g. of slow metabolisers)
- Psychiatric diagnoses and stressors were identified by other clinicians, so their role cannot be fully ruled out; including mixed psychiatric diagnoses makes the sample less homogeneous
Also worth weighing (library’s note)
- No control group and open-label, so change over 12 months cannot be separated from change that would have happened anyway. How long each man had had PSSD, or had been off the SSRI, at baseline is not reported (Table 2 gives onset only relative to starting or stopping)
- Treatments differed between men (nine regimens for 13 men); the text calls vortioxetine the most common and effective (p. 4) but also states the compounds could not be compared (p. 8)
- Questionnaire reporting is inconsistent: the IIEF-15 is described as 15 items each scored 0–5, which would total 0–75, but a 0–30 range with ED severity bands is used; the abstract refers to the "IIEF-5" and to improvement in all domains, but only one score per man is reported
- Statistical reporting is inconsistent: the significance threshold is given as p < 0.005, the text says the score improved significantly "(p > 0.05)", the abstract gives p < 0.05, and Table 3 gives p = 0.003
- The exclusion criterion for severe depression is written as a Hamilton score below 17, which reads as the reverse of excluding severe depression
- The outcome measures erectile and sexual function; the necessary diagnostic criterion (changed genital sensation) and the reported improvement in non-sexual symptoms (judged at interview) were not measured with a reported scale. Non-sexual problems at baseline are given only as approximate percentages (about 23% cognitive, 8% emotional, 25% both)
- The corresponding author is a co-author of the diagnostic criteria used (ref. 19) and of an earlier case report of a nutraceutical for PSSD (ref. 34)
Funding: Italian Ministry of Health ("current research" funding) Interests: None declared
What it can support (library’s note): That most of 13 men with PSSD at one clinic had higher erectile and sexual-function questionnaire scores a year after individually chosen treatments, most often vortioxetine. It cannot show that any treatment caused the change, or compare treatments.
Why it’s in the corpus
A small (13-man) uncontrolled treated PSSD series, suggesting vortioxetine-based regimens may help some patients. Central to the corpus's treatment-evidence section.
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