Study Of Generalized Anxiety Disorder

Phase 2

Completed

• Conditions: Anxiety Disorder; Anxiety Disorders
• Interventions: Drug: Placebo; Drug: Paroxetine

• Registration Number: NCT00135525
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-08-24
• Study First Submitted QC: 2005-08-24
• Study First Posted: 2005-08-26
• Primary Completion: 2005-10
• Study Completion: 2006-05
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-27
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Paroxetine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	8 Weeks