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A Combination Therapy In Patients With Social Anxiety Disorder

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Social Anxiety Disorder

Intervention: vestipitant/paroxetine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, PhD, Study Director, Affiliation: GlaxoSmithKline

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of Vestipitant and Paroxetine in patients with Social Anxiety Disorder (SAD)

Clinical Details

Official title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Comparing the Efficacy and Safety of GW597599/Paroxetine Combination or Paroxetine Monotherapy to Placebo in Patients With Social Anxiety Disorder (SAD)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change in score on a Social Anxiety Disorder rating scale following 12 weeks of treatment.

Secondary outcome: Change in score on a number of rating scales following 12 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder.

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Primary diagnosis of Generalised Social Anxiety Disorder as defined in DSM-IV.

- Capable of giving informed consent and willing to comply with the study requirements.

- Women of childbearing potential must agree to one of a number of defined acceptable

methods of birth control. Exclusion criteria:

- Primary diagnosis within the past 6 months of another Axis 1 disorder such as Major

Depression or another anxiety disorder.

- Use of medications for a psychiatric condition including herbals in the past 2-12

weeks according to medication type.

- Subjects who, in the investigator's judgement pose a current, serious suicidal or

homicidal risk or have made a suicide attempt within the past 6 months.

- Subjects who currently meet or who met within 6 months prior to screening DSM-IV

criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).

- Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).

Locations and Contacts

GSK Investigational Site, Hilleroed 3400, Denmark

GSK Investigational Site, Hvidovre 2650, Denmark

GSK Investigational Site, Koebenhavn K 1256, Denmark

GSK Investigational Site, Koebenhavn OE 2100, Denmark

GSK Investigational Site, Risskov 8240, Denmark

GSK Investigational Site, Skanderborg 8660, Denmark

GSK Investigational Site, Soroe 4180, Denmark

GSK Investigational Site, Berlin 10629, Germany

GSK Investigational Site, Berlin 13053, Germany

GSK Investigational Site, Bergen N-5068, Norway

GSK Investigational Site, Hamar N-2317, Norway

GSK Investigational Site, Oslo 0364, Norway

GSK Investigational Site, Sandvika 1338, Norway

GSK Investigational Site, Bloemfontein, South Africa

GSK Investigational Site, Tygerberg 7505, South Africa

GSK Investigational Site, Huettenberg, Hessen 35625, Germany

GSK Investigational Site, Achim, Niedersachsen 28832, Germany

Additional Information

Starting date: November 2004
Last updated: October 15, 2008

Page last updated: August 23, 2015

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