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Completed

NCT Number: NCT00921063

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

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

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PD 0332334

Drug

250 mg capsule, BID for 4 weeks

Other names: imagabalin

Placebo

Drug

0 mg capsule, BID for 4 weeks

Alprazolam extended release

Drug

1 mg capsule, BID for 4 weeks

Other names: Xanax XR

Primary outcomes

  1. HAM-A Total Score

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 1. 2. ands 4 weeks

  2. HAM-A somatic and psychic subscales

    Time frame: 1, 2, and 4 weeks

  3. HAM-A responders

    Time frame: 4 weeks

  4. HAM-A sustained responders

    Time frame: Week 1 through week 4

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

    Time frame: Day 2 through day 7

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

    Time frame: 1 and 4 weeks

  7. HAM-D total score

    Time frame: 1 and 4 weeks

  8. Sheehan Disability Score (SDS)

    Time frame: 4 weeks

  9. Treatment Satisfaction Questionaire for Medication

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 16, 2009
Registry last updated
Feb 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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