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
Secondary identifying numbers	BP12/2006

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

Study website

Contact information

Prof Ferran J García-Fructuoso
Scientific

Paseo Manuel Girona, 33
Servicio de Reumatología
Clínica CIMA
Barcelona
08034
Spain

Email	ferran.garcia@cimaclinic.com

Study information

Study design	A prospective double-blind, randomised, single-center, placebo-controlled, parallel group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tianeptine (moxonidine)
Primary outcome measure	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	1. The tender point score 2. The Hamilton Depression Anxiety inventory (HAD) 3. Short Form (SF-36) health survey.
Overall study start date	01/01/2007
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Sponsor information

Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica (Spain)
Research organisation

c/o Joan Güell
184 Local 27
Barcelona
08028
Spain

Email	info@fundacionfatiga.org
Website	http://www.fundacionfatiga.org
"ROR"	https://ror.org/03p4nrj93

Funders

Funder type

Research organisation

Foundation for Fibromialgia and Chronic Fatigue Syndrome (Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica) (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan