FibromyalgiaPhase 1/2NCT02451475
Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome
A Phase 1/2 study testing Amitriptyline, Venlafaxine and Paroxetine in people with Fibromyalgia, run by Mansoura University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Amitriptyline, Venlafaxine and Paroxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia
- Receiving pregabalin daily
Who cannot join
- Pathologies mimicking the symptoms of fibromyalgia
- Acute systemic inflammatory diseases
- Infections
- Pregnancy
- Lactating
About this study
Official title: Comparative Effectiveness of Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome: A Controlled Randomized Study
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.
Read the detailed description
Fibromyalgia is a common cause of chronic widespread disabling pain affecting 2-5% of the young to middle-aged women in developed countries. The American College of Rheumatology has been established new diagnostic criteria for fibromyalgia in 2010 included a widespread pain index (WPI) and categorical scales for cognitive symptoms, unrefreshed sleep, fatigue, and number of somatic symptoms. The definite pathophysiology of chronic pain in fibromyalgia remains unclear.
Fibromyalgia is usually associated with depression, anxiety, and alexithymia increasing over age which contribute significantly to reduced patient wellbeing. These may be due to alterations of central pain pathways, hyporeactivity of the hypothalamus-pituitary-adrenal axis, and disturbances in the dopaminergic and serotonergic systems. Thus the European League Against Rheumatism (EULAR) recommends the use of serotonin and noradrenaline reuptake inhibitors (SNRIs) for the treatment of fibromyalgia, to reduce pain and improve function.
However, few patients achieve satisfactory pain relief with the sole use of SNRIs. A recent Cochrane review demonstrated only modest improvement in relieving pain without reducing of sleep disturbances, fatigue, or the poor quality of life with the use of duloxetine and milnacipran than placebo in patients with fibromyalgia. More patients experienced adverse events like as nausea, dry mouth, constipation, headache, somnolence, dizziness and insomnia leading to stopping medications. Whereas, the evidence from clinical studies shows that combined use of pregabalin and SNRIs such as duloxetine has potential efficacy and better tolerability during the treatment of improvement of pain, fatigue, and sleep disorders in patients with fibromyalgia.
The use of the second-generation antidepressants like as paroxetine (a selective serotonin reuptake inhibitors (SSRIs)) and venlafaxine (SNRIs) may be associated with more tolerability and reduce pain in patients with major depressive disorder.
To the best of the investigator's knowledge, the comparison of the long-term efficacy, tolerability, and safety of the combined use of pregabalin with one of the three antidepressants, namely, amitriptyline, venlafaxine, or paroxetine for the treatment of fibromyalgia has not yet been studied.
The investigators hypothesized that the combined use of pregabalin and paroxetine would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and Center for Epidemiological Studies Depression scales (CESD) and higher tolerability than the use of pregabalin with either amitriptyline or venlafaxine.
- Conditions
- Fibromyalgia
- Being tested
- Amitriptyline, Venlafaxine, Paroxetine
- Keywords
- Pregabalin, Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
Amitriptyline 25 mg/day
VenlafaxineDrug
Venlafaxine 75 mg/day
ParoxetineDrug
Paroxetine 25 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Amitriptyline | Other | Amitriptyline 25 mg/day Receives: Drug: Amitriptyline |
| Venlafaxine | Active comparator | Venlafaxine 75 mg/day Receives: Drug: Venlafaxine |
| Paroxetine | Active comparator | Paroxetine 25 mg/day Receives: Drug: Paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatic Symptoms Scale-8 (SSS-8)
Using the 8-points Somatic Symptoms Score
Measured: for six months after start of the medication
Secondary outcomes (6)
Center for Epidemiological Studies Depression (CSED)
According to the Center for Epidemiological Studies Depression (CSED) questionnaire
Measured: for six months after start of the medication
Life satisfaction
Using a life satisfaction score
Measured: for six months after start of the medication
Mood
Using a mood score
Measured: for six months after start of the medication
Sleep quality
Using a sleep quality questionnaire
Measured: for six months after start of the medication
Fatigue
Using a fatigue questionnaire
Measured: for six months after start of the medication
Tolerability
Using a tolerability questionnaire
Measured: for six months after start of the medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed R El Tahan, Mansoura University
- Investigators
- Eiad Ramzy, MD, Principal investigator, Lecturer of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451475
- Sponsor's protocol ID
- MUH-ANES-2013-10
- Status last verified
- May 2015
- First submitted
- 16 May 2015
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome: A Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT02451475
- Acronym / sponsor ID
- MUH-ANES-2013-10
- Conditions
- Fibromyalgia
- Keywords
- Pregabalin, Fibromyalgia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fibromyalgia is a common cause of chronic widespread disabling pain affecting 2-5% of the young to middle-aged women in developed countries. The American College of Rheumatology has been established new diagnostic criteria for fibromyalgia in 2010 included a widespread pain index (WPI) and categorical scales for cognitive symptoms, unrefreshed sleep, fatigue, and number of somatic symptoms. The definite pathophysiology of chronic pain in fibromyalgia remains unclear.
Fibromyalgia is usually associated with depression, anxiety, and alexithymia increasing over age which contribute significantly to reduced patient wellbeing. These may be due to alterations of central pain pathways, hyporeactivity of the hypothalamus-pituitary-adrenal axis, and disturbances in the dopaminergic and serotonergic systems. Thus the European League Against Rheumatism (EULAR) recommends the use of serotonin and noradrenaline reuptake inhibitors (SNRIs) for the treatment of fibromyalgia, to reduce pain and improve function.
However, few patients achieve satisfactory pain relief with the sole use of SNRIs. A recent Cochrane review demonstrated only modest improvement in relieving pain without reducing of sleep disturbances, fatigue, or the poor quality of life with the use of duloxetine and milnacipran than placebo in patients with fibromyalgia. More patients experienced adverse events like as nausea, dry mouth, constipation, headache, somnolence, dizziness and insomnia leading to stopping medications. Whereas, the evidence from clinical studies shows that combined use of pregabalin and SNRIs such as duloxetine has potential efficacy and better tolerability during the treatment of improvement of pain, fatigue, and sleep disorders in patients with fibromyalgia.
The use of the second-generation antidepressants like as paroxetine (a selective serotonin reuptake inhibitors (SSRIs)) and venlafaxine (SNRIs) may be associated with more tolerability and reduce pain in patients with major depressive disorder.
To the best of the investigator's knowledge, the comparison of the long-term efficacy, tolerability, and safety of the combined use of pregabalin with one of the three antidepressants, namely, amitriptyline, venlafaxine, or paroxetine for the treatment of fibromyalgia has not yet been studied.
The investigators hypothesized that the combined use of pregabalin and paroxetine would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and Center for Epidemiological Studies Depression scales (CESD) and higher tolerability than the use of pregabalin with either amitriptyline or venlafaxine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amitriptyline | Other | Drug: AmitriptylineAmitriptyline 25 mg/day |
| Venlafaxine | Active comparator | Drug: VenlafaxineVenlafaxine 75 mg/day |
| Paroxetine | Active comparator | Drug: ParoxetineParoxetine 25 mg/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fibromyalgia
- Receiving pregabalin daily
Key exclusion criteria (5 listed)
- Pathologies mimicking the symptoms of fibromyalgia
- Acute systemic inflammatory diseases
- Infections
- Pregnancy
- Lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmitriptylineAmitriptyline 25 mg/day | Drug | Amitriptyline |
| VenlafaxineVenlafaxine 75 mg/day | Drug | Venlafaxine |
| ParoxetineParoxetine 25 mg/day | Drug | Paroxetine |
Primary outcome
Somatic Symptoms Scale-8 (SSS-8)
Time frame: for six months after start of the medication
Using the 8-points Somatic Symptoms Score
6 secondary outcomes
Center for Epidemiological Studies Depression (CSED)
Time frame: for six months after start of the medication
Life satisfaction
Time frame: for six months after start of the medication
Mood
Time frame: for six months after start of the medication
Sleep quality
Time frame: for six months after start of the medication
Fatigue
Time frame: for six months after start of the medication
Tolerability
Time frame: for six months after start of the medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eiad Ramzy, MD principal investigator
Lecturer of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Amitriptyline, Venlafaxine and Paroxetine in people with Fibromyalgia, run by Mansoura University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatic Symptoms Scale-8 (SSS-8) (time frame: for six months after start of the medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.