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NCT03487211: CORTEX
Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia
Phase 2, PHASE3 trial testing Duloxetine in Fibromyalgia in 200 participants. Completed in 26 February 2020.
26 February 2020
Quick facts
| Lead sponsor | Shaheed Zulfiqar Ali Bhutto Medical University |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 9 April 2018 |
| Primary completion | 26 February 2020 |
| Estimated completion | 26 February 2020 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- Duloxetine (duloxetine) — full drug profile →
- Escitalopram (escitalopram) — full drug profile →
Conditions studied
- Fibromyalgia — all drugs for Fibromyalgia →
Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
Who can join
Adults 18 to 70, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Duloxetine is FDA approved as pharmacological treatment for Fibromyalgia. The use of SSRIs has been endorsed by the 2013 Canadian guidelines. The data available for Escitalopram as a treatment modality for Fibromyalgia is limited, however small trials have demonstrated its efficacy. No head to head comparisons between escitalopram and duloxetine have been undertaken. We aim to conduct a single blind, randomized control trial to assess the comparative efficacy of duloxetine vs escitalopram in drug naive patients with newly diagnosed Fibromyalgia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497
Verify or expand the search:
- PubMed search for NCT03487211
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Duloxetine
Trials testing the same drug.
- NCT07431606 — Duloxetine in Inflammatory Bowel Diseases · Phase 2 · not yet recruiting
- NCT07326163 — The Effect of Peppermint Oil Aromatherapy on Pain, Functional Capacity and Cost in Fibromyalgia Patients · NA · enrolling by invitation
- NCT06860984 — Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatograph · Phase 3 · recruiting
- NCT06807866 — Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT · Phase 4 · recruiting
- NCT06711978 — Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a R · NA · not yet recruiting
Other recruiting trials for Fibromyalgia
Currently open trials in the same condition.
- NCT02285868 — ATI Evidence-based Guide Investigating Clinical Services · active not recruiting
- NCT07245303 — Neural Mechanisms of Light Driven Analgesia · NA · recruiting
- NCT05901259 — The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes · recruiting
- NCT07358754 — The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor · recruiting
- NCT07465991 — The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia · NA · recruiting
Other Shaheed Zulfiqar Ali Bhutto Medical University trials
Trials by the same sponsor.
- NCT06525844 — Regenerative Endodontic Therapy in Cases of Irreversible Pulpitis · NA · recruiting
- NCT06176430 — Comparison of Twice Weekly Versus Daily Iron Therapy in Treating Anemia in Children With Cerebral Palsy · Phase 4 · unknown
- NCT06234020 — Frequency of Vertebrospinal Anomalies in Patients Presenting With Anorectal Malformations · completed
- NCT06323642 — Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Ped · NA · unknown
- NCT06164158 — Role of Procedural Videos in Teaching the Surgery Residents · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03487211 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shaheed Zulfiqar Ali Bhutto Medical University
- Last refreshed: 27 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03487211.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing