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A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)

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NCT00658008

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Litchfield Park, Arizona, 85340 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

- Any of the following current (within the past 6 months through the present) DSM-IV
Axis I diagnosis: 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.

- 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.

- Antisocial or borderline personality disorder.

- Serious suicidal risk per the clinical investigator's judgment.

NCT00658008
Pfizer
Terminated
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)

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A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)
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
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, with generalized anxiety disorder.
Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Drug: PD 0332334
    Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
    Other Name: imagabalin
  • Drug: PD 0332334
    Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
  • Drug: PD 0332334
    Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
  • Drug: Paroxetine
    Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
  • Drug: Placebo
    Capsules, oral, placebo bid, 8 weeks with 2 week taper
  • Experimental: PD 0332334 175 mg BID
    Intervention: Drug: PD 0332334
  • Experimental: PD 0332334 225 mg BID
    Intervention: Drug: PD 0332334
  • Experimental: PD 0332334 75 mg BID
    Intervention: Drug: PD 0332334
  • Active Comparator: Paroxetine 20 mg QD
    Intervention: Drug: Paroxetine
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
501
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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).
  • Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnosis: 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.
  • 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.
  • Antisocial or borderline personality disorder.
  • Serious suicidal risk per the clinical investigator's judgment.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   Italy,   Korea, Republic of,   Russian Federation,   United States
 
 
NCT00658008
A5361019
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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