Experimental Medication For the Treatment of Generalized Anxiety Disorder

Jazz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Anxiety Disorder

Treatments: Drug: experimental anti-anxiety drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097708

JZP 04-001-01

Details and patient eligibility

About

The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Full description

Protocol 04-001-01

The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).

The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.

Recruiting: Participants are currently being recruited and enrolled.

Enrollment: 511 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.

Exclusion criteria

• No other primary psychiatric diagnosis besides GAD.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind