Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder

Novartis Pharmaceuticals400 enrolled

Overview

This study will test the efficacy, safety and tolerability of XBD173 in the treatment of generalized anxiety disorder in patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Anxiety Disorders

Interventions

XBD173DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Current doctor's diagnosis of generalized anxiety disorder * In need of psychiatric treatment * Willingness to complete all aspects of the study Exclusion Criteria: * Current doctor's diagnosis of major depression * History of schizophrenia or schizoaffective disorders * Drug dependence within 2 months prior to study start For detailed information on eligibility, please contact the study center nearest to you (see below), or call 1-862-778-8300, or visit the following website: www.novartisclinicaltrials.com

Locations (23)

Investigational Site

Anaheim, California, United States

Outcomes

Primary Outcomes

Mean reduction in anxiety from baseline to week 6

Secondary Outcomes

The difference on day 4 in effect between placebo and the individual doses of XBD173 on reduction in anxiety and depression

Pharmacokinetic assessments at baseline

Pharmacogenetic assessments at baseline

Pharmacogenomic and proteomic assessments at baseline

Metabonomic assessments at visits 4, 7 and 10

Data from ClinicalTrials.gov

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