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Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00836069
Recruitment Status : Terminated (Pfizer has terminated the execution of this protocol)
First Posted : February 4, 2009
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Itai Danovitch, Cedars-Sinai Medical Center

Brief Summary:

This study is a randomized, double-blind, parallel-group, multi-site, Phase 3, placebo controlled fixed-dose study of PD 0332334 and paroxetine in 528 outpatients with generalized anxiety disorder. Subjects will be randomized to the following treatments (132 subjects per treatment group):

PD 0332334 225 mg twice a day (450 mg/day), PD 0332334 300 mg twice a day (600 mg/day), placebo once a day in the morning or paroxetine 20 mg once a day in the morning (20 mg/day).


Condition or disease Intervention/treatment Phase
Anxiety Disorders Drug: No drug name provided by Sponsor; drug referenced as PD 0332334 Drug: Paroxetine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: PD 0332334-α2δ ligand (450mg)
PD 0332334, 450mg/day, for 8 weeks and then 2 weeks of dose tapering.
Drug: No drug name provided by Sponsor; drug referenced as PD 0332334
Experimental study drug for generalized anxiety disorder, oral tablet, at a total daily dose of 450mg or 600mg, twice daily for 8 weeks and then 2 weeks of dose tapering.

Experimental: PD 0332334-α2δ ligand (600mg)
PD 0332334, 600mg/day, for 8 weeks and then 2 weeks of dose tapering.
Drug: No drug name provided by Sponsor; drug referenced as PD 0332334
Experimental study drug for generalized anxiety disorder, oral tablet, at a total daily dose of 450mg or 600mg, twice daily for 8 weeks and then 2 weeks of dose tapering.

Active Comparator: Paroxetine
Paroxetine, 20mg/daym for 8 weeks and then 2 weeks of dose tapering.
Drug: Paroxetine
FDA Approved medication for generalized anxiety disorder, oral tablet, at 20mg, once daily for 8 weeks and then 2 weeks of dose tapering.
Other Name: Paxil, Paxil CR, Brisdelle, and Pexeva

Placebo Comparator: Placebo
Inactive Substance (placebo) for 10 weeks.
Drug: Placebo
inactive substance, oral tablet, once per day, for 10 weeks.




Primary Outcome Measures :
  1. Hamilton Anxiety Scale [ Time Frame: Every Week for 10 weeks ]
    The purpose of administering the scale is to analyze the severity of the patient's anxiety and will take approximately 10 to 15 minutes to administer.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  1. Diagnosis of generalized anxiety disorder (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician.
  2. Subjects must have a Hamilton-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 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 (Visit 1) and Randomization (Visit 2) 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.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  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) Diagnostic and Statistical Manual of Mental Disorders-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 Diagnostic and Statistical Manual of Mental Disorders-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-Mental State Examination diagnostic interview and the Columbia-Suicide Severity Rating Scale should be used as aids to the assessment of suicidality, but do not replace overall clinical judgment 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 the medical monitor and the investigator, the medical monitor may allow minimal anxiolytic medication (for example a benzodiazepine) use for subjects who experience significant intolerable 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 (Visit 1) or Randomization (Visit 2) 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 (Visit 1) 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 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 anxiety disorder (with an adequate trial of therapy).
  21. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of the study.
  22. Treatment with an investigational drug within 60 days preceding the first dose of trial medication.
  23. Estimated creatinine clearance <55 mL/min (using Cockcroft-Gault equation).
  24. Alanine aminotransferase or aspartate aminotransferase (AST) levels >3 times the upper limit of normal at Screening (Visit 1).
  25. Male and Female subjects with a screening 12-lead ECG demonstrating QTcF (Fredericia's correction) >450 msec, if confirmed with an unscheduled repeat 12-lead ECG's at the screen visit. In the event of discrepant QTcF values (i.e., >450 msec and <450 msec) after repeat unscheduled 12-lead ECG at screen, a decision with regards protocol eligibility will be made on a case by case basis between the investigator and medical monitor.
  26. History of lack of efficacy for treatment of generalized anxiety disorder with, or allergy or intolerance to, other α2δ drugs (pregabalin, gabapentin).
  27. Blood donation of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  28. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836069


Locations
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United States, California
Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Pfizer
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Responsible Party: Itai Danovitch, Chair, Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00836069    
Other Study ID Numbers: 15002
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Itai Danovitch, Cedars-Sinai Medical Center:
Generalized Anxiety Disorder
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors