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Trial record 54 of 135 for:    AMITRIPTYLINE

Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome

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ClinicalTrials.gov Identifier: NCT02451475
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Amitriptyline Drug: Venlafaxine Drug: Paroxetine Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome: A Controlled Randomized Study
Study Start Date : February 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Amitriptyline
Amitriptyline 25 mg/day
Drug: Amitriptyline
Amitriptyline 25 mg/day

Active Comparator: Venlafaxine
Venlafaxine 75 mg/day
Drug: Venlafaxine
Venlafaxine 75 mg/day

Active Comparator: Paroxetine
Paroxetine 25 mg/day
Drug: Paroxetine
Paroxetine 25 mg/day




Primary Outcome Measures :
  1. Somatic Symptoms Scale-8 (SSS-8) [ Time Frame: for six months after start of the medication ]
    Using the 8-points Somatic Symptoms Score


Secondary Outcome Measures :
  1. Center for Epidemiological Studies Depression (CSED) [ Time Frame: for six months after start of the medication ]
    According to the Center for Epidemiological Studies Depression (CSED) questionnaire

  2. Life satisfaction [ Time Frame: for six months after start of the medication ]
    Using a life satisfaction score

  3. Mood [ Time Frame: for six months after start of the medication ]
    Using a mood score

  4. Sleep quality [ Time Frame: for six months after start of the medication ]
    Using a sleep quality questionnaire

  5. Fatigue [ Time Frame: for six months after start of the medication ]
    Using a fatigue questionnaire

  6. Tolerability [ Time Frame: for six months after start of the medication ]
    Using a tolerability questionnaire



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fibromyalgia
  • Receiving pregabalin daily

Exclusion Criteria:

  • Pathologies mimicking the symptoms of fibromyalgia
  • Acute systemic inflammatory diseases
  • Infections
  • Pregnancy
  • Lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451475


Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Eiad Ramzy, MD Lecturer of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt

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Responsible Party: Mohamed R El Tahan, Associate Professor, Mansoura University
ClinicalTrials.gov Identifier: NCT02451475     History of Changes
Other Study ID Numbers: MUH-ANES-2013-10
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by Mohamed R El Tahan, Mansoura University:
Pregabalin
Fibromyalgia
Additional relevant MeSH terms:
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Amitriptyline
Amitriptyline, perphenazine drug combination
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Paroxetine
Venlafaxine Hydrochloride
Antidepressive Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents