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

Sponsored by:	Pfizer
Information provided by:	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:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	600
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Pregabalin Pregabalin 150-300 mg given twice a day
2: Active Comparator	Drug: Lorazepam Lorazepam 3-4 mg given twice a day
3: Experimental	Drug: Pregabalin Pregabalin 450-600 mg given twice a day
4: Placebo Comparator	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 of GAD. 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 39 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, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081147
Study First Received:	February 15, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00624780 History of Changes
Health Authority:	Finland: National Agency of Medicines (Lääkelaitos)

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Pregabalin
Central Nervous System Depressants
Antiemetics
Lorazepam

Anxiety Disorders
Mental Disorders
Hypnotics and Sedatives
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Lorazepam
Pathologic Processes
Sensory System Agents
Mental Disorders
Therapeutic Uses
Hypnotics and Sedatives
Analgesics

Disease
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Pregabalin
Pharmacologic Actions
Anxiety Disorders
Autonomic Agents
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 04, 2009