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A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Beverly Hills, California, 90210 United States
Contact
1-800-718-1021
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 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 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.

- 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.

NCT00542685
Pfizer
Completed
A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

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A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Drug: PD 0332334
    Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
    Other Name: imagabalin
  • Drug: Placebo
    Capsules, oral, placebo BID, 8 weeks with 2 week taper.
  • Drug: PD 0332334
    Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
  • Drug: PD 0332334
    Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
  • Experimental: PD 0332334 300 mg BID
    Intervention: Drug: PD 0332334
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
  • Experimental: PD 0332334 225 mg BID
    Intervention: Drug: PD 0332334
  • Experimental: PD 0332334 175 mg BID
    Intervention: Drug: PD 0332334
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
551
December 2008
December 2008   (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 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.
  • 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
United States
 
 
NCT00542685
A5361017
Yes
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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