EUCTR2008-000762-23-HU进行中（未招募）不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, 10-WEEK, PLACEBO CONTROLLED FIXED DOSE STUDY OF PD 0332334 AND PAROXETINE EVALUATING THE EFFICACY AND SAFETY OF PD 0332334 FOR THE TREATMENT OF GENERALIZED ANXIETY DISORDER
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
- 658
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. Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
- •2. Subjects must have a HAM-A total score =20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of =9 and a Raskin Depression Scale score =7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.
- •3. Otherwise healthy men or nonpregnant, nonlactating women (women must be using a hormonal or barrier method of contraception or be postmenopausal or surgically sterilized). Healthy is defined as no other clinically relevant abnormalities identified by a detailed medical history, full physical examination including sitting blood pressure (BP) and heart rate measurement, 12-lead ECG, and clinical laboratory tests.
- •4. Age 18 to 65 years, inclusive.
- •5. All women must have negative pregnancy tests at the Screening (V1) and Randomization (V2) visits.
- •6. Evidence of a personally signed and dated informed consent document indicating that the subject 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. Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
- •2. Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses:
- •Major depressive disorder; Obsessive compulsive disorder; Panic disorder; Agoraphobia; Posttraumatic stress disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder; Alcohol or substance abuse or dependence unless in full remission for at least 6 months; Social anxiety disorder.
- •3. Any of the following past or current DSM-IV Axis I diagnoses:
- •Schizophrenia; Psychotic disorder; Delirium, dementia, amnestic, and other clinically significant cognitive disorders; Bipolar or schizoaffective disorder; Cyclothymic disorder; Dissociative disorders.
- •4. Antisocial or borderline personality disorder.
- •5. Serious suicidal risk per the clinical investigator’s judgment. (Note: The Suicidality module of the MINI diagnostic interview and the C-SSRS should be used as aids to the assessment of suicidality, but do not replace overall clinical judgement in determination of suicidal risk).
- •6. Current use of psychotropic medications (ie, drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 5 weeks of randomization. In the event of inadvertent administration of psychotropic medications during the 2 weeks prior to randomization, continued eligibility will be assessed on a case by case basis by the investigator and the medical monitor
- •7. Use of drugs, supplements, prescription or nonprescription, or food that have psychoactive properties. In the event of inadvertent use of such products during the 2 weeks prior to randomization, continued eligibility will be assessed on a case by case basis by the investigator and the medical monitor. In addition, following a discussion of the individual case between medical monitor and the investigator, the medical monitor may allow minimal anxiolytic medication (for example a benzodiazepine) use for subjects who experience significant anxiety during the final week of the study (Days 64-71).
- •8. Subjects who have been treated with monoamine oxidase inhibitors in the 14 days prior to the baseline visit.
- •9. Regular use of benzodiazepines during the 3 months prior to Screening (for at least 5 out of 7 days per week).
- •10. Subjects initiating formal psychotherapy within 3 month prior to screening who intend to continue formal psychotherapy during the study. This includes psychodynamic, cognitive, and interpersonal therapies.
- •11. Positive drug tests at Screening (V1) or Randomization (V2) visits for any of the following substances or classes of compounds: amphetamines, barbiturates, opiates,
- •benzodiazepines, sedatives and hypnotics, cocaine, phencyclidine (PCP), cannabinoids, or other illegal or illicit drugs. An exception to the exclusion for a positive benzodiazepine, opiate, or sedative and hypnotic drug test at the Screening
- •(V1) visit may be granted by the Pfizer medical monitor if written evidence of a valid,
- •current prescription is presented.
- •12. Any condition possibly affecting drug absorption (eg, gastrectomy).
- •13. Subjects with a current seizure disorder.
- •14. Subjects with a history of life-threatening neoplasms within 5 years prior to study entr
研究者
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