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Study Of Generalized Anxiety Disorder

Primary Purpose

Anxiety Disorder, Anxiety Disorders

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paroxetine
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder focused on measuring Generalized Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Paroxetine

    Placebo

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Mean change from baseline in the Hamilton Anxiety Scale (HAM-A) total score (at Week 8, last observation carried forward [LOCF])

    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

    Full Information

    First Posted
    August 24, 2005
    Last Updated
    January 27, 2011
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00135525
    Brief Title
    Study Of Generalized Anxiety Disorder
    Official Title
    Clinical Evaluation of BRL29060 A in Generalized Anxiety Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2003 (undefined)
    Primary Completion Date
    October 2005 (Actual)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorder, Anxiety Disorders
    Keywords
    Generalized Anxiety Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    Paroxetine
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Paroxetine
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Of Generalized Anxiety Disorder

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