Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

Comparative Effectiveness of Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome: A Controlled Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451475
• Other study ID #: MUH-ANES-2013-10
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 16, 2015
• Last updated: May 21, 2015
• Start date: February 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Amitriptyline
Amitriptyline 25 mg/day
• Venlafaxine
Venlafaxine 75 mg/day
• Paroxetine
Paroxetine 25 mg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

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