Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder

NCT00836069 | Terminated Phase 3

• 1 other identifier: 15002
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, parallel-group, multi-site, Phase 3, placebo controlled fixed-dose study of PD 0332334 and paroxetine in 528 outpatients with generalized anxiety disorder. Subjects will be randomized to the following treatments (132 subjects per treatment group): PD 0332334 225 mg twice a day (450 mg/day), PD 0332334 300 mg twice a day (600 mg/day), placebo once a day in the morning or paroxetine 20 mg once a day in the morning (20 mg/day).

Conditions

Anxiety Disorders

Keywords

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Scale

  The purpose of administering the scale is to analyze the severity of the patient's anxiety and will take approximately 10 to 15 minutes to administer.

  Every Week for 10 weeks

Study Arms (4)

PD 0332334-α2δ ligand (450mg)

EXPERIMENTAL

PD 0332334, 450mg/day, for 8 weeks and then 2 weeks of dose tapering.

Drug: No drug name provided by Sponsor; drug referenced as PD 0332334

PD 0332334-α2δ ligand (600mg)

EXPERIMENTAL

PD 0332334, 600mg/day, for 8 weeks and then 2 weeks of dose tapering.

Drug: No drug name provided by Sponsor; drug referenced as PD 0332334

Paroxetine

ACTIVE COMPARATOR

Paroxetine, 20mg/daym for 8 weeks and then 2 weeks of dose tapering.

Drug: Paroxetine

Placebo

PLACEBO COMPARATOR

Inactive Substance (placebo) for 10 weeks.

Drug: Placebo

Interventions

No drug name provided by Sponsor; drug referenced as PD 0332334 DRUG

Experimental study drug for generalized anxiety disorder, oral tablet, at a total daily dose of 450mg or 600mg, twice daily for 8 weeks and then 2 weeks of dose tapering.

PD 0332334-α2δ ligand (450mg); PD 0332334-α2δ ligand (600mg)

Paroxetine DRUG

FDA Approved medication for generalized anxiety disorder, oral tablet, at 20mg, once daily for 8 weeks and then 2 weeks of dose tapering.

Also known as: Paxil, Paxil CR, Brisdelle, and Pexeva

Paroxetine

Placebo DRUG

inactive substance, oral tablet, once per day, for 10 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of generalized anxiety disorder (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02) as established by the clinician.
• Subjects must have a Hamilton-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.
• Otherwise healthy men or non-pregnant, non-lactating women (women must be using a hormonal or barrier method of contraception or be postmenopausal or surgically sterilized). Healthy is defined as no other clinically relevant abnormalities identified by a detailed medical history, full physical examination including sitting blood pressure and heart rate measurement, 12-lead ECG, and clinical laboratory tests.
• Age 18 to 65 years, inclusive.
• All women must have negative pregnancy tests at the Screening (Visit 1) and Randomization (Visit 2) visits.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• 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) Diagnostic and Statistical Manual of Mental Disorders-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 Diagnostic and Statistical Manual of Mental Disorders-IV Axis I diagnoses:
• Schizophrenia;

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Pfizer: collaborator

Study Sites (1)

Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Psychiatry and Behavioral Neurosciences

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2010
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)