Tianeptine for the treatment of fibromyalgia: a prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study
Completed
- Conditions
- Fibromyalgia (FM)Musculoskeletal Diseases
- Registration Number
- ISRCTN16400909
- Lead Sponsor
- Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. The tender point score<br>2. The Hamilton Depression Anxiety inventory (HAD)<br>3. Short Form (SF-36) health survey.