Clinical trial NCT01432236: A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression
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 (Protocol A0081275)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: Pregabalin
Lyrica
depression
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean NRS Pain Score at End of Period.
timeFrame: End of each period, at Weeks 6 and 14
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.
timeFrame: Baseline
measure: FIQ Score at End of Period.
timeFrame: End of each period, at Weeks 6 and 14
measure: Patient Global Impression of Change (PGIC) at the End of Period 1.
timeFrame: End of Period 1 at Week 6
measure: Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary.
timeFrame: Visits 2, 6, and 12
measure: Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.
timeFrame: End of each period, at Weeks 6 and 14
measure: Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period.
timeFrame: End of each period, at Weeks 6 and 14
measure: Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period.
timeFrame: End of each period, at Weeks 6 and 14
measure: Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period.
timeFrame: End of each period, at Weeks 6 and 14
measure: Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period.
timeFrame: End of each period, at Weeks 6 and 14
measure: Hospital Anxiety and Depression Scale (HADS) at Baseline.
timeFrame: Baseline
measure: HADS at End of Period.
timeFrame: End of each period, at Weeks 6 and 14
measure: Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline.
timeFrame: Baseline
measure: EQ-5D Score at End of Period.
timeFrame: End of each period, at Weeks 6 and 14
Other outcomes:
measure: PGIC at the End of Period 2.
timeFrame: End of Period 2 at Week 14
measure: Mean Patient Static Global Assessment (PSGA) Score at Baseline.
timeFrame: Baseline
measure: Mean PSGA Score at End of Period.
timeFrame: End of each period, at Weeks 6 and 14
measure: Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline.
timeFrame: Baseline
measure: Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline.
timeFrame: From Visit 3 to Visit 14
measure: Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline.
timeFrame: Baseline
measure: Health Utilization Assessment (Total Office Visits, Number of Hospitalizations and Number of Emergency Room Visits) at Baseline.
timeFrame: Baseline
measure: Health Utilization Assessment (Time for Help no Payment) at Baseline.
timeFrame: Baseline
Locations:
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Orange
country: United States
facility: SDS Clinical Trials
state: California
city: Santa Ana
country: United States
facility: Research Across America
state: California
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Florida Medical Center & Research, Inc.
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Columbus
country: United States
facility: Medical Research and Health Education Foundation, Inc.
state: Georgia
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Wyomissing
country: United States
facility: Behavioral Medicine Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLP
state: Pennsylvania
city: East Greenwich
country: United States
facility: Coastal Medical
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Salt Lake City
country: United States
facility: Fatigue Consultation Clinic
state: Utah
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research, LC
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Penticton
country: Canada
facility: Dr. Alexander McIntyre Inc.
state: British Columbia
city: Thornhill
country: Canada
facility: Canadian Centre for Clinical Trials
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Milano
country: Italy
facility: Azienda Ospedaliera Luigi Sacco - Polo Universitario
city: Roma
country: Italy
facility: Università degli Studi di Roma "La Sapienza"
city: Barcelona
country: Spain
facility: Hospital de lˊEsperança
city: Barcelona
country: Spain
facility: Instituto Universitario USP Dexeus
city: Barcelona
country: Spain
facility: Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Guadalajara
country: Spain
facility: Hospital General Universitario de Guadalajara
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Bateman L, Sarzi-Puttini P, Burbridge CL, Landen JW, Masters ET, Bhadra Brown P, Scavone JM, Emir B, Vissing RS, Clair AG, Pauer LR. Burden of illness in fibromyalgia patients with comorbid depression. Clin Exp Rheumatol. 2016 Mar-Apr;34(2 Suppl 96):S106-13. Epub 2016 Mar 10.
citation: Arnold LM, Sarzi-Puttini P, Arsenault P, Khan T, Bhadra Brown P, Clair A, Scavone JM, Driscoll J, Landen J, Pauer L. Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study. J Rheumatol. 2015 Jul;42(7):1237-44. doi: 10.3899/jrheum.141196. Epub 2015 Jun 1.