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
- Conditions
- Generalized Anxiety Disorder (GAD)MedDRA version: 9.1Level: LLTClassification code 10018105Term: Generalized anxiety disorder
- Registration Number
- EUCTR2008-000761-32-DE
- Lead Sponsor
- Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 528
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 non-pregnant, non-lactating 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
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 but not seasonal allergies)
2. Any of the following current 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 ( MINI)
6. Current use of psychotropic medications 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
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
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 or Randomization visits for any of the following substances or classes of compounds: amphetamines, barbiturates, opiates, benzodiazepines, sedatives and hypnotics, cocaine, phencyclidine, 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 or Randomisation visits 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
13. Subjects with a current seizure disorder
14. Subjects with a history of life-threatening neoplasms within 5 years prior to study entry, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin
15. Subjects with hypothyroidism or hyperthyroidism, except subjects who are euthyroid and have been on stable doses of thyroid replacement for 6 months or more.
16. Subjects with any clinically unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disorder.
17. Subjects with uncontrolled narrow angle glaucoma
18. Subjects with a known hypersensitivity to paroxetine
19. History of allergy or intolerance to paroxetine
20. Subjects with a prior history of insufficient response to paroxetine in the treatment of generalized anxiet
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method