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

Generalized Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921063
• Other study ID #: A5361007
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2009
• Last updated: February 17, 2010
• Start date: November 2005
• Est. completion date: July 2006

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• PD 0332334
250 mg capsule, BID for 4 weeks
• PD 0332334
100 mg capsule, BID for 4 weeks
• placebo
0 mg capsule, BID for 4 weeks
• Alprazolam extended release
1 mg capsule, BID for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAM-A Total Score		4 weeks	No
Secondary	HAM-A total score at week 1, 2 and 4		1. 2. ands 4 weeks	No
Secondary	HAM-A somatic and psychic subscales		1, 2, and 4 weeks	No
Secondary	HAM-A responders		4 weeks	No
Secondary	HAM-A sustained responders		Week 1 through week 4	No
Secondary	DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)		Day 2 through day 7	No
Secondary	CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)		1 and 4 weeks	No
Secondary	HAM-D total score		1 and 4 weeks	No
Secondary	Sheehan Disability Score (SDS)		4 weeks	No
Secondary	Treatment Satisfaction Questionaire for Medication		4 weeks	No

External Links

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