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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Generalized Anxiety Disorder

Treatments: Drug: placebo; Drug: Alprazolam extended release; Drug: PD 0332334

Study type: Interventional

Funder types: Industry

Identifiers

NCT00921063

A5361007

Details and patient eligibility

About

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

Enrollment: 222 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

222 participants in 4 patient groups, including a placebo group

PD 0332334 250 mg

Experimental group

Treatment:

Drug: PD 0332334

Drug: PD 0332334

PD 0332334 100 mg

Experimental group

Treatment:

Drug: PD 0332334

Drug: PD 0332334

placebo

Placebo Comparator group

Treatment:

Drug: placebo

Alprazolam extended release

Active Comparator group

Treatment:

Drug: Alprazolam extended release