Study Of Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00135525
First received: August 24, 2005
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

This study is designed to evaluate the efficacy and safety in Generalized Anxiety Disorder patients


Condition Intervention Phase
Anxiety Disorder
Anxiety Disorders
Drug: Paroxetine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of BRL29060 A in Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline in the Hamilton Anxiety Scale (HAM-A) total score (at Week 8, last observation carried forward [LOCF]) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline in the HAM-A score (at Weeks 1, 2, 4 and 6); in the Severity of Illness (CGI SI) score; in the SDS and MADRS total scoreProportion of responders based on the Clinical Global Impression Global Improvement (CGI GI) score [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Study Start Date: May 2003
Study Completion Date: May 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paroxetine

Fixed Dose (20 mg/day): The fixed dose of 20 mg/day was selected, because it is the recommended dose for the treatment of GAD in the US and other countries.

Flexible Dose (20 - 40 mg/day): Overseas, the maximum dose in the treatment of GAD is 50 mg/day. However, 40 mg/day was selected as the maximum dose for this flexible dose session, because overseas clinical studies have indicated that paroxetine is sufficiently effective at doses of 20 - 40 mg/day and this is the dose range approved for depression/depressive episodes in Japan.

Drug: Paroxetine

Fixed Dose (20 mg/day): The fixed dose of 20 mg/day was selected, because it is the recommended dose for the treatment of GAD in the US and other countries.

Flexible Dose (20 - 40 mg/day): Overseas, the maximum dose in the treatment of GAD is 50 mg/day. However, 40 mg/day was selected as the maximum dose for this flexible dose session, because overseas clinical studies have indicated that paroxetine is sufficiently effective at doses of 20 - 40 mg/day and this is the dose range approved for depression/depressive episodes in Japan.

Placebo Comparator: Placebo Drug: Placebo
Placebo

Detailed Description:

This study was a multi-center, randomized, placebo-controlled, double-blinded (placebo run-in will be single-blinded), group comparison study.

Paroxetine 20mg/day (achieved via the starting dose of 10 mg/day for the first week) once daily, or placebo was orally administered once daily for 8 weeks (fixed dose was adopted in the Treatment phase) in patients with GAD.

For subjects who were classed as non-responders at Week 8, paroxetine at 30 to 40mg/day (once daily) or placebo (once daily) was orally administered with flexible titration regimen for 4 weeks (fixed dose was adopted in the Treatment phase). The subjects underwent a taper phase in case they received Paroxetine 40mg/day, paroxetine 30mg/day or placebo at treatment completion or study withdrawal. A follow-up examination was conducted after 1 to 5 weeks from the last dose of the investigational product.

The overall study duration requiring subject participation was 10 to 20 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Generalized Anxiety Disorder (GAD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
  • Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.

Exclusion Criteria:

  • Have the following conditions currently or diagnosed in the past 24 weeks:

Major Depressive Episode, Panic Disorder Without Agoraphobia, Panic Disorder With Agoraphobia, Social phobia/social anxiety disorder (SAD), Agoraphobia Without History of Panic Disorder, Posttraumatic Stress Disorder, Obsessive Compulsive Disorder, Anorexia Nervosa, Bulimia Nervosa, Dysthymic disorder

  • Current or history of schizophrenia, bipolar disorder or cyclothymic disorder.
  • Psychotherapy or cognitive behavioral therapy other than supportive psychotherapy.
  • Current or history of substance abuse (alcohol or drugs) or substance in past 24 weeks.
  • Taken St. John's Wort in past 4 weeks.
  • Had electroconvulsive therapy (ECT) in past 12 weeks.
  • Had psychotherapy or cognitive behavioral therapy other than supportive psychotherapy within 24 weeks.
  • Women who are pregnant or lactating, who may be pregnant, or who plan for pregnancy by 30 days after the completion of final dose.
  • Pose a suicidal threat or have attempted suicide in past 24 weeks.
  • History of convulsive disorder (epilepsy, etc.).
  • Significant unstable medical illness.
  • Current or history of glaucoma.
  • History or complication of cancer or malignant tumor.
  • History of hypersensitivity to paroxetine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135525

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00135525     History of Changes
Other Study ID Numbers: BRL29060A/856
Study First Received: August 24, 2005
Last Updated: January 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014