DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: PD 0332334 (Drug); PD 0332334 (Drug); placebo (Drug); Alprazolam extended release (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population

Clinical Details

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 5-Week Trial To Assess The Efficacy And Safety Of PD 0332334 Compared To Placebo And Alprazolam Extended-Release In Patients With Generalized Anxiety Disorder

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: HAM-A Total Score

Secondary outcome:

HAM-A total score at week 1, 2 and 4

HAM-A somatic and psychic subscales

HAM-A responders

HAM-A sustained responders

DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)

CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)

HAM-D total score

Sheehan Disability Score (SDS)

Treatment Satisfaction Questionaire for Medication

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD)

(Diagnostic and Statistical Manual-IV [DSM-IV], 300. 02).

- HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both

Screening and Baseline/Randomization. Exclusion Criteria:

- Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive

Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;

- Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder;

Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder

- Current use of psychotropic medications (i. e., drugs normally prescribed for

depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2005
Last updated: February 17, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017