Summary
Fluoxetine Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Stroke (Ischaemic / Cerebrovascular Disease) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Stroke (Ischaemic / Cerebrovascular Disease). ClinicalTrials.gov lists 1 registered trial linking Fluoxetine Hydrochloride to Stroke (Ischaemic / Cerebrovascular Disease): 1 has completed. The most advanced is Phase 2 (NCT03448159). It plans or enrolled 52 participants. Registered activity dates to 2019. The literature layer holds 5 publications for this pair: 1 Cochrane review, 1 meta-analysis and 3 clinical trial publications. Publication years run from 2010 to 2021. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Ischemic Stroke ranks 577 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous early neurological improvement in 10-20% within 24 hours of ischaemic stroke without intervention; functional independence at 3 months in only 40-50% without revascularisation; 15% 30-day mortality untreated.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 38.5 (trials 3.5, literature 15.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 5 (3 clinical trial publications, 1 Cochrane review, 1 meta-analysis) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ACE |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT03448159 | Fluoxetine Opens Window to Improve Motor Recovery After Stroke 2019 | completed | Phase 2 | 52 |
Published literature
- Clinical trial publication Depression Outcomes Among Patients Treated With Fluoxetine for Stroke Recovery: The AFFINITY Randomized Clinical TrialAlmeida OP, Hankey GJ, Ford A et al. · JAMA neurology · 2021 · PMID 34338714
- Cochrane review Meta-analysis of the clinical effectiveness of combined acupuncture and Western Medicine to treat post-stroke depressionWang X, Xiong J, Yang J et al. · Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan · 2021 · PMID 33522192
- Meta-analysis Efficacy and safety of modified Sini San for treating poststroke depression: A meta-analysis of randomized controlled trialsCai L, Jiejie L, Hu Y et al. · Explore (New York, N.Y.) · 2021 · PMID 32527684
- Clinical trial publication [Effect of early intervention of liver-smoothing and blood-activating decoction combined with acupuncture on patients with post-stroke depression]Hu JF, Chen CJ, Bi XL et al. · Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica · 2013 · PMID 24199581
- Clinical trial publication Clinical studies on event-related potentials (ERPs) N400 and the related factors in patients with poststroke depression (PSD)He W, Cai D, Lin L et al. · International journal of psychiatry in medicine · 2010 · PMID 21166343
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ACE. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Fluoxetine Hydrochloride approved for Stroke (Ischaemic / Cerebrovascular Disease)?
Fluoxetine Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Stroke (Ischaemic / Cerebrovascular Disease) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Stroke (Ischaemic / Cerebrovascular Disease). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Fluoxetine Hydrochloride in clinical trials for Stroke (Ischaemic / Cerebrovascular Disease)?
ClinicalTrials.gov lists 1 registered trial linking Fluoxetine Hydrochloride to Stroke (Ischaemic / Cerebrovascular Disease): 1 has completed. The most advanced is Phase 2 (NCT03448159). It plans or enrolled 52 participants. Registered activity dates to 2019.
What does the evidence show for Fluoxetine Hydrochloride in Stroke (Ischaemic / Cerebrovascular Disease)?
Fluoxetine Hydrochloride has both completed registered trials and synthesis-level publications linked to Stroke (Ischaemic / Cerebrovascular Disease). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ACE. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.