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Pregabalin and Duloxetin in fibromyalgia treatment

Depression and pain improvement in patients with fibromyalgia syndrome with duloxetin or pregsbalin: a comparative open labeled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016030626935N1
Enrollment
70
Registered
2016-07-06
Start date
2016-04-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia. Fibromyalgia

Interventions

Intervention 1: Duloxetin 30 mg once daily and if tolerate increase to 60 mg once daily for 3 next week. Intervention 2: Pregabalin 75 mg once daily and after 1 week if tolerate increase to 75 mg twic
Treatment - Drugs
Duloxetin 30 mg once daily and if tolerate increase to 60 mg once daily for 3 next week.
Pregabalin 75 mg once daily and after 1 week if tolerate increase to 75 mg twice daily for 3 next 3 week

Sponsors

Vice Chancellor for Research of Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: fibromyalgia patients; age between 18 to 65; Exclusion criteria: receiving Duloxetine, Pregabalin and Gabapentin with other antidepressants during the 12 weeks before entering the study; pregnancy or have a plan to become pregnant during the study; underlying rheumatic disease, cancer, and other diseases that can cause chronic pain which has not been defined in the fibromyalgia syndrome; having a job or duties which need high concentration or alertness; use of MAOI (monoamine oxidase inhibitors) within 14 days before study; chronic liver disease, severe renal failure and uncontrolled narrow-angle glaucoma; history of hypersensitivity to Pregabalin and its components

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: At the begining and 4 weeks after treatment. Method of measurement: FIQ and WPI questionaire.;Depression. Timepoint: At the begining and 4 weeks after treatment. Method of measurement: SF-12 and becks questionaire.

Secondary

MeasureTime frame
Drug adverse reactions. Timepoint: 1 week after start the drug. Method of measurement: Drug adverse reactions questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shahrzad Rahmani

Iran University of Medical Science

shz_rahmani@yahoo.com+98 21 4438 7425

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 3, 2026