EUCTR2006-006339-31-EE进行中（未招募）不适用
AN 8 WEEK, DOUBLE BLIND, PLACEBO CONTROLLED, PHASE 3 TRIAL OF PREGABALIN (150 600 MG/DAY) IN THE ADJUNCTIVE TREATMENT OF PATIENTS WITH GENERALIZED ANXIETY DISORDER (GAD) WHO HAVE NOT OPTIMALLY RESPONDED TO EXISTING THERAPIES - N/A
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, United states0 个研究点目标入组 865 人开始时间: 2007年5月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 865
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •1. Males and females 18 years of age or older.
- •2. Primary DSM IV diagnosis of GAD (DSM IV, 300.02), as confirmed by the MINI structured interview.
- •3. All patients must have a total HAM A score =22 at screening.
- •4. Patients who initiated GAD treatment prior to entering the study must have a CGI I = 3 minimally improved or worse as determined by the physician’s assessment of a patient’s response to the treatment (escitalopram, paroxetine, or venlafaxine XR) at study enrollment (Visit 1).
- •5. Patients who initiated the GAD treatment at enrollment (Visit 1) must have a minimum score of CGI S = 4 at Screening (Visit 0) and Enrollment (Visit 1).
- •6. Historical failure to respond optimally to a GAD treatment (CGI I =3 minimally improved or worse). This treatment must be a different treatment than the one used during the open label optimization phase of this study and must be included in the treatments listed in Table 1, Appendix 1 (in the protocol). GAD treatments not included in Table 1, Appendix 1 (in the protocol), but which the investigator considers to meet this criterion must be discussed with and approved by the sponsor in advance of enrolling the patient in the study.
- •7. Able to understand and cooperate with study procedures and to give informed consent.
- •8. 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 trial.
- •9. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial 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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following will not be included in the trial:
- •1. Current* primary DSM IV diagnosis of major depressive disorder (MDD single episode, recurrent) with or without seasonal pattern, dysthymic disorder, depressive disorder NOS, social phobia, panic disorder with or without agoraphobia, post traumatic stress disorder (PTSD), dissociative disorder, borderline personality disorder, obsessive compulsive disorder, antisocial personality disorder, as defined in the DSM IV TR. If a subject has a past misdiagnosis of any of these disorders, the investigator will need to contact the sponsor prior to screening.
- •2. Past and/or current DSM IV diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder).
- •3. DSM IV substance (except for nicotine and caffeine) dependence within the past 30 days.
- •4. Presence of comorbid personality disorders (Axis II) based on DSM IV criteria per the investigator’s clinical judgment.
- •5. Suicide risk by history, self report, or clinically judged to be at serious suicidal or homicidal risk.
- •6. No change is permitted in the status of psychotherapy for the duration of the study. Ongoing psychotherapy of stable intensity is allowed.
- •7. Urine drug screen at screening (Visit 0) positive for amphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine. At randomization drug screen positive subjects for any of these substances or THC are excluded from participation in the double blind phase.
- •8. 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. Patients must be on stable thyroid replacement therapy for hypothyroidism for at least 2 weeks prior to screening (Visit 0);
- •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.
- •9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2 times the upper limit of normal.
- •10. Platelet count <125,000/mm3.
- •11. Serum sodium >150 or <130 mEq/L.
- •12. Creatinine clearance (CLcr) =60 mL/min (estimated from serum creatinine obtained at Visit 0, body weight, age, and gender using the Cockcroft and Gault equation, Safety Assessments Laboratory). Subjects who have an estimated CLcr =60 mL/min by this screening method may have their CLcr measured, at the investigator’s discretion, with a 24 hour urine collection performed at the central laboratory. If this 24 hour urine CLcr is >60 mL/min, the subject is not excluded. For SI units see Section 7.5.
- •13. Clinically significant abnormal electrocardiogram (ECG), including but not limited to the following abnormalities:
- •Rhythm Conduction: Premature ventricular contractions >10/min; ventricular tachycardia; ventricular flutter; ventricular fibrillation; second degree AV block (Mobitz Type 1); second degree AV block (Mobitz Type 2); complete heart block; Wolff Parkinson White Syndrome; or left bundle branch block complete;
- •Myocardial infarction: Recent or acute (<3 months prior to screening/Visit 0);
- •QRS, ST T: ST T changes or abnormal Q (=30 ms) compatible with ischemia; QTc prolongation (>500 msec); or QRS prolongation (>140
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