Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00624780

Purpose

The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: Pregabalin Drug: Lorazepam Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Pregabalin Lorazepam

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety endpoints: Adverse events at 3 and 6 months, Physicians Withdrawal Checklist (PWC), Rebound Anxiety (HAM-A), Discontinuation Emergent Signs and Symptoms (DESS) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
Efficacy endpoints: Hamilton Anxiety Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement (CGI-I). [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse events [ Time Frame: through study ] [ Designated as safety issue: Yes ]
Suicidality [ Time Frame: through study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	May 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Pregabalin Pregabalin 150-300 mg given twice a day Other Name: Lyrica
Active Comparator: 2	Drug: Lorazepam Lorazepam 3-4 mg given twice a day
Experimental: 3	Drug: Pregabalin Pregabalin 450-600 mg given twice a day Other Name: Lyrica
Placebo Comparator: 4	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis Generalized Anxiety Disorder
HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline
Needs pharmacological treatment

Exclusion Criteria:

Current or past diagnosis of any other DSM IV Axis I disorders
A history of failed treatment with a benzodiazepine
Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624780

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 60 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00624780 History of Changes
Other Study ID Numbers:	A0081147
Study First Received:	February 15, 2008
Last Updated:	February 9, 2012
Health Authority:	Finland: National Agency of Medicines (Lääkelaitos)

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Pregabalin
Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents

Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on February 09, 2012