The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia

NCT07186751 | Recruiting DMC

• 1 other identifier: KY2025-217-03-03
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 2

Brief Summary

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of venlafaxine in FM. We hypothesize that the combination of pregabalin with venlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.

Conditions

Fibromyalgia; Pregabalin; Venlafaxine; Pain

Outcome Measures

Primary Outcomes (1)

• The average pain intensity

  The average pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days at the 4 weeks. This will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

  At the 4-weeks

Secondary Outcomes (9)

• The worst pain intensity

  At the weeks 1, 2, 4, 8, and 12

• The proportion of patients achieving pain reduction

  At the weeks 1, 2, 4, 8, and 12

• Dose of pregabalin and/or venlafaxine

  At the weeks 1, 2, 4, 8, and 12

• The Revised FM Impact Questionnaire

  At the weeks 1, 2, 4, 8, and 12

• The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales

  At the weeks 1, 2, 4, 8, and 12

Study Arms (2)

Pregabalin monotherapy group

ACTIVE COMPARATOR

Drug: Pregabalin

Pregabalin with venlafaxine group

EXPERIMENTAL

Drug: Pregabalin with venlafaxine

Interventions

Pregabalin DRUG

In general, for the pregabalin monotherapy group (Pregabalin Capsules, Pfizer, New York, USA), treatment will be initiated at 150 mg/day, administered in two divided doses. After 7 days, the dose will be increased to 300 mg/day. Thereafter, based on individual response and tolerability, the dose may be further increased to a maximum of 450 mg/day.

Pregabalin monotherapy group

Pregabalin with venlafaxine DRUG

For the combination therapy group, participants will receive both pregabalin and venlafaxine (Venlafaxine Hydrochloride Sustained-Release Capsules, Pfizer, Co Kildare, Ireland). The dose titration for pregabalin will be identical to that of the monotherapy group. Concurrently, venlafaxine will be initiated at 75 mg/day. If well-tolerated, the dose may be increased in 75 mg/day increments at weekly intervals, guided by clinical response and side effects profile, to a maximum dose of 225 mg/day.

Pregabalin with venlafaxine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
• Aged more than 18 years;
• Suffering from moderate to severe FM with 11-point numeric rating scale (NRS) score more than 4 at baseline that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
• Agreed to sign the informed consent form.

You may not qualify if:

• A history of psychiatric disease;
• Hypersensitivity or have contraindications to pregabalin, venlafaxine;
• Pregnancy or breastfeeding;
• Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, significant cardiac dysfunction, or chronic hepatic or renal dysfunction;
• With acute or chronic pain conditions other than FM.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• China-Japan Friendship Hospital: collaborator
• First Affiliated Hospital of Army Medical University, PLA: collaborator
• Second Affiliated Hospital of Guangxi Medical University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Peking University Third Hospital: collaborator

Study Sites (2)

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijin, China

RECRUITING

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

RECRUITING

Related Links

• Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315
• Migliorini F, Maffulli N, Eschweiler J, Baroncini A, Bell A, Colarossi G. Duloxetine for fibromyalgia syndrome: a systematic review and meta-analysis. J Orthop Surg Res. 2023;18(1):504. doi: 10.1186/s13018-023-03995-z.
• Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, et al. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558.
• VanderWeide LA, Smith SM, Trinkley KE. A systematic review of the efficacy of venlafaxine for the treatment of fibromyalgia. J Clin Pharm Ther. 2015;40(1):1-6. doi: 10.1111/jcpt.12216.

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Pregabalin; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Central Study Contacts

Fang Luo

CONTACT

+8613611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Pain Management, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 22, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 15, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)