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)

INTERVENTION: Trade Name: Lyrica® Pharmaceutical Form: Capsule, hard CAS Number: 148553‐50‐8 Other descriptive name: PREGABALIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Lyrica® Pharmaceutical Form: Capsule, hard CAS Number: 148553‐50‐8 Other descriptive name: PREGABALIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Lyrica® Pharmaceutical Form: Capsule, hard CAS Number: 148553‐50‐8 Other descriptive name: PREGABALIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 225‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] This study will be conducted in subjects with fibromyalgia. Subjects will also be on concurrent medication for comorbid depression. ; MedDRA version: 14.0 Level: PT Classification code 10048439 Term: Fibromyalgia System Organ Class: 10028395 ‐ Musculoskeletal and connective tissue disorders PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of pregabalin compared with placebo in subjects with fibromyalgia and comorbid depression currently on a stable SSRI or SNRI primarily being used to treat the depression. Primary end point(s): Endpoint mean pain score, based on the mean of the last 7 daily pain NRS scores from the daily pain diaries while receiving study medication in each treatment period; (eg, daily pain diary (0‐10 numeric rating scale)). Secondary Objective: To evaluate the safety and tolerability of pregabalin in this population. Timepoint(s) of evaluation of this end point: Daily pain IVRS diaries will be completed continuously from week 0 to14. SECONDARY OUTCOME: Secondary end point(s): ‐ Fibromyalgia Impact Questionnaire (FIQ);; ‐ Patient Global Impression of Change (PGIC) at the end of Period 1 (V6);; ‐ Proportions of subjects with ?30% and ?50% pain reduction based on daily pain diary;; ‐ Subjective Sleep Questionnaire (daily diary; 5 questions);; ‐ Hospital Anxiety and Depression Scale (HADS); and; ‐ EuroQoL 5‐Dimensions (EQ‐5D). Timepoint(s) of evaluation of this end point: FIQ, weeks 0, 6,14, PGIC, weeks 6, 14; daily pain diary proportions of subjects with pain reduction and Subjective Sleep Questionnaire, using the same analysis methods as specified for the primary efficacy endpoint, weeks 6 and 14, HADS, weeks ‐1, 0, 6, 14, EQ‐5D, weeks 0, 6, 14 INCLUSION CRITERIA: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including the training and completion of the daily pain and sleep diaries using Interactive Voice Response System (IVRS). 3. Men or women of any race or ethnicity who are at least 18 years of age. 4. Men or women must use appropriate methods of contraception. Women must be nonpregnant and nonlactating,postmenopausal, or surgically sterilized; women of childbearing potential must use appropriate methods of contraception (including barrier or hormonal method); all women must have a confirmed negative serum pregnancy test at baseline. 5. At screening (V1), subjects must meet the 1990 ACR criteria for fibromyalgia (eg, widespread pa