Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

Viatris

Status and phase: Completed; Phase 4

Conditions: Generalized Anxiety Disorder

Treatments: Drug: Placebo; Drug: Lorazepam; Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00624780

A0081147

Details and patient eligibility

About

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).

Enrollment: 615 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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615 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

2

Active Comparator group

Treatment:

Drug: Lorazepam

3

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

4

Placebo Comparator group

Treatment:

Drug: Placebo