A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 8, 2011
Last updated: August 7, 2013
Last verified: August 2013

The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.

Condition Intervention Phase
Drug: Pregabalin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b Multicenter, Double-Blind, Randomized, Placebo-Controlled, 2-Way Crossover Study of Pregabalin in the Treatment of Fibromyalgia With Concurrent Antidepressant Therapy for Comorbid Depression

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint mean pain score, based on the mean of the last 7 daily pain NRS scores from the daily pain diaries [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective Sleep Questionnaire (daily diary; 5 questions) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Visits 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Visits 6 and 12 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Visits 1, 2, 6 and `12 ] [ Designated as safety issue: Yes ]
  • EuroQoL 5 Dimensions (EQ 5D) [ Time Frame: Visits 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Patient Static Global Assessment (PSGA) [ Time Frame: Visits 2, 6, and 12 ] [ Designated as safety issue: No ]
  • Columbia Suicide Severity Rating Scale (C SSRS). [ Time Frame: Visits 1-14 ] [ Designated as safety issue: Yes ]
  • Work Productivity and Activity Index Specific Health Problem (WPAI SHP) [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
  • Health Utilization Assessment [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]

Enrollment: 195
Study Start Date: October 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin
Group 1 as Pregabalin vs. Placebo (cross over study in which period one has this group)
Drug: Pregabalin
Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose
Placebo Comparator: Placebo
Group 2 as placebo vs. pregabalin (cross over study in which period two will have this group)
Drug: placebo
placebo capsules twice a day for 14 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women of any race or ethnicity who are at least 18 years of age.
  • Adult women and men with a diagnosis of fibromyalgia and stable depression (major depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have been taking an antidepressant (SSRI or SNRI) primarily for their depression for at least 3 months.

Exclusion Criteria:

  • Have failed pregabalin treatment due to lack of improvement of symptoms at doses of greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of improvement or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.
  • Patients with severe or unstable depression are not eligible.
  • Patients with other types of pain or conditions that may make it difficult to evaluate fibromyalgia symptoms are not eligible
  • Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432236

  Show 37 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01432236     History of Changes
Other Study ID Numbers: A0081275
Study First Received: September 8, 2011
Last Updated: August 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Depressive Disorder
Myofascial Pain Syndromes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 14, 2014