Tianeptine for the treatment of fibromyalgia: a prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study
| ISRCTN | ISRCTN16400909 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16400909 |
| Protocol serial number | BP12/2006 |
| Sponsor | Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica (Spain) |
| Funder | Foundation for Fibromialgia and Chronic Fatigue Syndrome (Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica) (Spain) |
- Submission date
- 21/09/2006
- Registration date
- 05/10/2006
- Last edited
- 05/10/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ferran J García-Fructuoso
Scientific
Scientific
Paseo Manuel Girona, 33
Servicio de Reumatología
Clínica CIMA
Barcelona
08034
Spain
| ferran.garcia@cimaclinic.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A prospective double-blind, randomised, single-center, placebo-controlled, parallel group study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Fibromyalgia (FM) is a common illness that affects approximately 2.5 to 13% of the general population, of which the majority (10/1) are female. FM is characterised by chronic widespread pain and sleeping problems. Patients with FM frequently have other symptoms such as headaches, nocturnal jaw tightness, morning stiffness, tingling and numbness of arms and legs, irritable bowel, urinary urgency, dryness in the mouth and eyes, cold swollen hands, anxiety and/or depression. Another characteristic of FM is tenderness at palpation in defined points at the neck and lower back areas. Tianeptine is an antidepressant agent with a novel neurochemical profile. It increases serotonin (5-HydroxyTryptamine [5-HT]) uptake in the brain (in contrast with most antidepressant agents), promotes neuroplasticity and reduces stress-induced atrophy of neuronal dendrites. Like the Selective Serotonin Reuptake Inhibitors (SSRIs) and in contrast with most tricyclic antidepressant agents, tianeptine does not appear to be associated with adverse cognitive, psychomotor, sleep, cardiovascular or bodyweight effects and has a low propensity for abuse. This study assess the efficacy and safety of tianeptine in patients with FM. |
| Ethics approval(s) | Comité Ético de Investigación Clínica de Clínica, International Centre of Advanced Medicine (Centro Internacional de Medicina Avanzada [CIMA]) (Barcelona, Spain) (reference number: 0036/2006CIMA), date of approval is 10th August 2006. |
| Health condition(s) or problem(s) studied | Fibromyalgia (FM) |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tianeptine (moxonidine) |
| Primary outcome measure(s) |
The primary outcome was improvement in the pain score (10 cm Visual Analog Scale [VAS]) at 24 weeks and Fibromyalgia Impact Qiestionnnaire (FIQ) score. |
| Key secondary outcome measure(s) |
1. The tender point score |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Aged from 40 to 50 years, both genders 2. Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria |
| Key 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 |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Spain
Study participating centre
Paseo Manuel Girona, 33
Barcelona
08034
Spain
08034
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
