EUCTR2007-004768-32-GR进行中（未招募）不适用
ONG TERM SAFETY AND EFFICACY STUDY OF PREGABALIN IN SUBJECTS WITH GENERALIZED ANXIETY DISORDER - N/A
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 794
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women age 18 to 65 years. Women of childbearing potential must use a reliable method of birth control during the study period.
- •2. Primary DSM IV diagnosis of GAD (DSM IV, 300.02)8 as established by a psychiatrist or licensed clinical psychologist and confirmed by the Mini-International Neuropsychiatric Interview (MINI) structured interview.9
- •3. HAM A total score =14 and item #1 on the HAM D with a depressed mood score =2 at both the Screening (Visit 1) and Baseline (Visit 2) visits to ensure predominance of anxiety symptoms over depression.
- •4. Subjects who require pharmacologic treatment for GAD.
- •5. Able to understand and cooperate with study procedures and to give informed consent.
- •6. 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.
- •7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •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
排除标准
- •1. Current or past diagnosis of any other DSM IV Axis I disorders (including current premenstrual dysphoric disorder) with the following exceptions:
- •Current or past depression not otherwise specified, specific phobia, or somatization disorder; and
- •Past history of major depressive disorder, social phobia, panic disorder, or of an eating disorder.
- •2. DSM IV substance (except for nicotine and caffeine) abuse or dependence within the past 6 months.
- •3. Presence of comorbid borderline and antisocial personality disorders, based on DSM IV criteria per the investigator’s clinical judgment.
- •4. Suicide risk by history within past 2 years, self-report, or clinically judged to be at serious suicidal or homicidal risk.
- •5. Stopping or initiating psychotherapy for GAD in Period 2 or 3. Subjects with psychotherapy of stable intensity for at least 6 weeks or more are allowed to enter the study.
- •6. Daily use of benzodiazepines for treating GAD (?5 days/week) during the 3 months prior to screening. Occasional use of benzodiazepine for insomnia is allowed but not within 2 weeks of baseline.
- •7. Current use of psychotropic medications that can not be discontinued 2 weeks prior to baseline (5 weeks for fluoxetine).
- •8. A history of failed treatment with lorazepam as determined by the clinical judgment of the investigator and taking into account adequacy of dose and the duration of treatment.
- •9. Known sensitivity to lorazepam or other benzodiazepines.
- •10. Prior exposure to pregabalin.
- •11. A positive urine drug screen at screening for any of the following substances or classes of compounds: amphetamines, barbiturates, benzodiazepines, narcotics, sedatives and hypnotics, cocaine, phencyclidine, cannabinoids, or other illegal or illicit drugs.
- •12. A positive breathalyzer test at screening.
- •13. Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder, including, but not limited to:
- •Any seizure disorder.
- •Uncorrected hypothyroidism or hyperthyroidism. Subjects must be on stable thyroid replacement therapy for hypothyroidism for at least 6 weeks prior to screening.
- •History of life-threatening neoplasm treated within the last 5 years, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- •History of migraine headaches occurring more than once a month.
- •Narrow angle glaucoma.
- •14. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >3 tmes the upper limit of normal.
- •15. Platelet count <100,000/mm3.
- •16. Serum sodium >150 or <130 mEq/L.
- •17. Creatinine clearance (CLcr) <45 mL/min (estimated by Cockroft-Gault method).
- •18. Clinically significant electrocardiogram (ECG) abnormalities.
- •19. Pregnancy or lactation.
- •20. Participation in an experimental drug study within the last 30 days.
- •21. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or sponsor, would make the subject inappropriate for entry into this study.
研究者
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