Safety and Efficacy Evaluation of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Generalized Anxiety Disorder
Intervention: Pregabalin (Lyrica) (Drug); Lorazepam (Drug); Pregabalin (Lyrica) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
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).
Clinical Details
Official title: Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Safety endpoints: Adverse events at 3 and 6 months, Physicians Withdrawal Checklist (PWC), Rebound Anxiety (HAM-A), Discontinuation Emergent Signs and Symptoms (DESS)Efficacy endpoints: Hamilton Anxiety Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement (CGI-I).
Secondary outcome: Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of GAD; HAM-A score >14 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 lorazepam
- any clinically significant, serious, or unstable hematologic, autoimmune, endocrine,
cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Buenos Aires C1405BOA, Argentina
Pfizer Investigational Site, Tampere 33100, Finland
Pfizer Investigational Site, Kaunas 50185, Lithuania
Pfizer Investigational Site, Kaunas 50425, Lithuania
Pfizer Investigational Site, Klaipeda 94231, Lithuania
Pfizer Investigational Site, Vilnius 09112, Lithuania
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2008
Ending date: December 2010
Last updated: September 11, 2008
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