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OpenTrials
Completed

NCT Number: NCT00108836

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

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

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Key information

Conditions

Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XBD173

Drug

Primary outcomes

  1. Mean reduction in anxiety from baseline to week 6

Secondary outcomes

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

  2. Pharmacokinetic assessments at baseline

  3. Pharmacogenetic assessments at baseline

  4. Pharmacogenomic and proteomic assessments at baseline

  5. Metabonomic assessments at visits 4, 7 and 10

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Apr 20, 2005
Registry last updated
May 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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