Fibromyalgia Clinical Trial
Official title:
Comparative Effectiveness of Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome: A Controlled Randomized Study
Verified date | May 2015 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
Background: The investigator hypothesized that the combined use of pregabalin and paroxetine
would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and higher tolerability
than amitriptyline or venlafaxine.
Methods: After ethical approval, 75 patients with diagnosed fibromyalgia who were receiving
pregabalin 75 mg/day, were randomly allocated to receive amitriptyline 25 mg/day (n = 24),
venlafaxine 75 mg/day (n = 25), or paroxetine 25 mg/day (n = 26). All patients were assessed
bi-monthly for consequent six months for the changes in the SSS-8, Center for
Epidemiological Studies Depression Scale (CESDS), life satisfaction, mood, sleep quality,
fatigue and medication tolerability and adverse effects.
Status | Completed |
Enrollment | 75 |
Est. completion date | October 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Fibromyalgia - Receiving pregabalin daily Exclusion Criteria: - Pathologies mimicking the symptoms of fibromyalgia - Acute systemic inflammatory diseases - Infections - Pregnancy - Lactating |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Somatic Symptoms Scale-8 (SSS-8) | Using the 8-points Somatic Symptoms Score | for six months after start of the medication | Yes |
Secondary | Center for Epidemiological Studies Depression (CSED) | According to the Center for Epidemiological Studies Depression (CSED) questionnaire | for six months after start of the medication | Yes |
Secondary | Life satisfaction | Using a life satisfaction score | for six months after start of the medication | No |
Secondary | Mood | Using a mood score | for six months after start of the medication | No |
Secondary | Sleep quality | Using a sleep quality questionnaire | for six months after start of the medication | No |
Secondary | Fatigue | Using a fatigue questionnaire | for six months after start of the medication | No |
Secondary | Tolerability | Using a tolerability questionnaire | for six months after start of the medication | Yes |
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