Generalized Anxiety Disorder MedDRA version: 7.0 Level: LLT Classification code 10018105
Conditions
Interventions
Trade Name: Lyrica
Product Name: Lyrica
Product Code: PD 0144723 (CI-1008)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
Sponsors
Pfizer Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Signed and dated informed consent will be obtained from each subject (only include those able to consent) in accordance with the local regulatory and legal requirements. 2. Ages 18 to 65 years. 3. Male or female outpatient. 4. A primary diagnosis of DSM-IV-TRTM (2000) GAD (for criteria refer to Appendix F of the protocol). GAD will be diagnosed with the MINI International Neuropsychiatric Interview (M.I.N.I) Version 5.0.0. The more detailed Module P GAD from the M.I.N.I. Plus (Version 5.0.0) will be used to assess the GAD diagnosis specifically. 5. Hamilton Anxiety Rating Scale (HAM-A) total score > 20 and a score of > 10 on both the psychic and somatic factor scores at screening and baseline. 6. At least 4 Global Anxiety Visual Analogue Scale assessments must be completed between screening and baseline. 7. At least 4 Daily Pain Rating Scale assessments must be completed between screening and baseline. 8. Screening laboratory values must be within normal limits, or abnormalities must be clinically insignificant. Liver function tests > 2 times the upper limit of normal are considered significant. 9. Females of childbearing potential must have a negative serum b-HCG pregnancy test and be practicing an effective form of contraception (accepted methods are hormonal [oral contraceptive or injectable contraceptive], double barrier with spermicide, or intrauterine device-IUD). Complete abstinence may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer monitor prior to any screening tests or procedures for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Hamilton Depression Rating Scale (17-item HAM-D) score > 15 or score of > 2 on item 1 (depressed mood) of HAM-D. (Refer to Appendix I of the protocol) 3. A current DSM-IV-TRTM (2000) diagnosis of major depressive disorder, dysthymia, obsessive-compulsive disorder, posttraumatic stress disorder, body dysmorphic disorder or eating disorder at screening or within the past 6 months. 4. DSM-IV-TRTM (2000) diagnosis of substance abuse or dependence within the last 6 months prior to screening. (Refer to Appendix G of the protocol) 5. Mental condition, including mental retardation, rendering the individual unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude. 6. A current or lifetime diagnosis of schizophrenia, or any other psychotic disorder, or bipolar disorder. 7. A history of a seizure disorder, except febrile seizures of childhood. 8. Creatinine clearance = 60 ml/min (estimated from serum creatinine, body weight, age, and sex using the Cockroft-Gault equation (refer to Appendix E of the protocol)). Subjects who have an estimated creatinine clearance of less than 60 ml/min by this screening method may, at the investigator’s discretion, have their creatinine clearance measured with a 24-hour urine collection, performed at the central laboratory. If this 24-hour urine creatinine clearance is greater than 60 ml/min, the subject may be randomized. 9. Receiving psychotherapy (e.g., cognitive therapy, cognitive-behavioral therapy, supportive therapy or others) in which the specific focus of the therapy is GAD and its symptoms, or another anxiety disorder. Subjects who are contemplating beginning a course of psychotherapy and/or behavioral therapy during the study. Subjects already receiving psychotherapy (unrelated to the treatment of GAD or any other anxiety disorder) for at least 3 months prior to screening may be entered, provided their therapy remains unrelated to the treatment of GAD or other anxiety disorder, and there is no change in the type of therapy, or therapist during the study. 10. Received or have required electroconvulsive therapy within six (6) months prior to study entry. 11. Antidepressant, anxiolytic, antipsychotic, sedative (other than zopiclone or zolpidem for insomnia), hypnotic or psychoactive drug use within 2 weeks (5 weeks for fluoxetine) prior to the baseline visit or during the study. If medication is required for the treatment of insomnia during the one-week wash-out, zopiclone (3.75 mg per night) or zolpidem (5 mg per night) may be taken intermittently (prn) on two or fewer nights until 3 days before baseline. 12. Received depot neuroleptics within the previous 6 months of the baseline visit. 13. All herbal psychoactive treatments within 14 days of the baseline visit. 14. Daily and/or regular use of benzodiazepines at any dose within 4 weeks of the baseline visit. 15. Urine screen positive for benzodiazepines at Screening and/or Baseline Visit. 16. Requiring concomitant therapy with any psychotropic drug or drug with a psychotropic component during the course of the study (If medication is required for the treatment of insomnia during the one-week wash-o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Pregabalin and Venlafaxine XR (extended release) compared to placebo in the treatment of GAD).; Secondary Objective: To evaluate onset of activity of pregabalin in comparison to placebo and venlafaxine XR in the treatment of GAD symptoms at day 4 of double-blind treatment and to evaluate, through a subject-rated global scale, the efficacy of pregabalin in decreasing GAD symptoms, on a daily basis during the first week of double blind treatment. To evaluate the effect of pregabalin in the treatment of GAD, on improvement in quality of life, sexual satisfaction, disability, sleep and pain. To evaluate the effect of pregabalin and venlafaxine XR in the treatment of depressive symptoms experienced by non-depressed patients diagnosed with GAD. To evaluate the safety of pregabalin and venlafaxine XR in GAD, including overall tolerability, effects on sexual functioning, discontinuations due to adverse events, and discontinuation-emergent symptoms. ;Primary end point(s): The primary efficacy parameter is the Hamilton Anxiety Scale (HAM-A), which is assessed at each study visit. | — |
Countries
Ireland, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed