Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome
Comparative Effectiveness of Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome: A Controlled Randomized Study
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 16, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedMay 22, 2015
May 1, 2015
1.6 years
May 16, 2015
May 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Somatic Symptoms Scale-8 (SSS-8)
Using the 8-points Somatic Symptoms Score
for six months after start of the medication
Secondary Outcomes (6)
Center for Epidemiological Studies Depression (CSED)
for six months after start of the medication
Life satisfaction
for six months after start of the medication
Mood
for six months after start of the medication
Sleep quality
for six months after start of the medication
Fatigue
for six months after start of the medication
- +1 more secondary outcomes
Study Arms (3)
Amitriptyline
OTHERAmitriptyline 25 mg/day
Venlafaxine
ACTIVE COMPARATORVenlafaxine 75 mg/day
Paroxetine
ACTIVE COMPARATORParoxetine 25 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- Fibromyalgia
- Receiving pregabalin daily
You may not qualify if:
- Pathologies mimicking the symptoms of fibromyalgia
- Acute systemic inflammatory diseases
- Infections
- Pregnancy
- Lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eiad Ramzy, MD
Lecturer of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 16, 2015
First Posted
May 22, 2015
Study Start
February 1, 2013
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
May 22, 2015
Record last verified: 2015-05