Tianeptine for the treatment of fibromyalgia: a prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16400909

Enrollment

Registered

2006-10-05

Start date

2007-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia (FM) Musculoskeletal Diseases Fibromyalgia (FM)

Interventions

Group one - intervention group: Three month supply of oral Tianeptine (tablets) 12.5 mg every eight hours. Group two - control group: Identical placebo every eight hours.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged from 40 to 50 years, both genders 2. Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria

Exclusion criteria

Exclusion criteria: 1. Psychiatric illness 2. Major depression 3. Suicidal risk 4. Substance abuse 5. Pulmonary dysfunction 6. Renal impairment 7. Active cardiac disease 8. Liver disease 9. Autoimmune disease 10. Cancer 11. Sleep apnea 12. Chronic fatigue syndrome 13. Inflammatory bowel disease 14. Contraindications to tianeptine

Design outcomes

Primary

Measure	Time frame
The primary outcome was improvement in the pain score (10 cm Visual Analog Scale [VAS]) at 24 weeks and Fibromyalgia Impact Qiestionnnaire (FIQ) score.	—

Secondary

Measure	Time frame
1. The tender point score 2. The Hamilton Depression Anxiety inventory (HAD) 3. Short Form (SF-36) health survey.	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026