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

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: Paroxetine,Paxil	Phase II Phase III

Further Study Details: 

Primary Outcomes: Mean change from baseline in the HAM-A total score (at Week 8, LOCF)
Secondary Outcomes: Mean change from baseline in the HAM-A score (at Weeks 1, 2, 4 and 6) Mean change from baseline in the SDS and MADRS total score Proportion of responders based on the CGI GI score Mean change from baseline in the CGI SI score
Expected Total Enrollment:  340

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male and female outpatients, 18 years and up.
• Diagnosis of Generalized Anxiety Disorder (GAD) according to 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/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.

Japan
      GSK Clinical Trials Call Center, Sapporo-city,  003,  Japan
      GSK Clinical Trials Call Center, Sapporo-city,  060,  Japan
      GSK Clinical Trials Call Center, Ichikawa-city,  272,  Japan
      GSK Clinical Trials Call Center, Tokyo,  160,  Japan
      GSK Clinical Trials Call Center, Tokyo,  101,  Japan
      GSK Clinical Trials Call Center, Tokyo,  113,  Japan
      GSK Clinical Trials Call Center, Tokyo,  105,  Japan
      GSK Clinical Trials Call Center, Mitaka-city,  181,  Japan
      GSK Clinical Trials Call Center, Komae-city,  201,  Japan
      GSK Clinical Trials Call Center, Tokyo,  142,  Japan
      GSK Clinical Trials Call Center, Tokyo,  113,  Japan
      GSK Clinical Trials Call Center, Tokyo,  154,  Japan
      GSK Clinical Trials Call Center, Tokyo,  107,  Japan
      GSK Clinical Trials Call Center, Tachikawa-city,  190,  Japan
      GSK Clinical Trials Call Center, Tokyo,  101,  Japan
      GSK Clinical Trials Call Center, Kanazawa-City,  920,  Japan
      GSK Clinical Trials Call Center, Kanazawa-City,  920,  Japan
      GSK Clinical Trials Call Center, Hakusan-City,  924,  Japan
      GSK Clinical Trials Call Center, Kyoto-city,  602,  Japan
      GSK Clinical Trials Call Center, Kyoto-city,  602,  Japan
      GSK Clinical Trials Call Center, Kyoto-city,  606,  Japan
      GSK Clinical Trials Call Center, Osaka-city,  545,  Japan
      GSK Clinical Trials Call Center, Suita-city,  565,  Japan
      GSK Clinical Trials Call Center, Takatsuki-city,  569,  Japan
      GSK Clinical Trials Call Center, Moriguchi-city,  570,  Japan
      GSK Clinical Trials Call Center, Osakasayama-city,  589,  Japan
      GSK Clinical Trials Call Center, Moriguchi-city,  570,  Japan
      GSK Clinical Trials Call Center, Suita-city,  564,  Japan
      GSK Clinical Trials Call Center, Ikeda-city,  563,  Japan
      GSK Clinical Trials Call Center, Osaka-city,  577,  Japan
      GSK Clinical Trials Call Center, Osaka-city,  572,  Japan
      GSK Clinical Trials Call Center, Neyagawa-city,  572,  Japan
      GSK Clinical Trials Call Center, Osakasayama-city,  589,  Japan
      GSK Clinical Trials Call Center, Osaka-city,  530,  Japan
      GSK Clinical Trials Call Center, Kobe-city,  651,  Japan
      GSK Clinical Trials Call Center, Amagasaki-city,  660,  Japan
      GSK Clinical Trials Call Center, Kashihara-city,  634,  Japan
      GSK Clinical Trials Call Center, Hiroshima-city,  730,  Japan
      GSK Clinical Trials Call Center, Hiroshima-city,  734,  Japan
      GSK Clinical Trials Call Center, Hiroshima-city,  734,  Japan
      GSK Clinical Trials Call Center, Tokushima-city,  770,  Japan
      GSK Clinical Trials Call Center, Tokushima-city,  770,  Japan
      GSK Clinical Trials Call Center, Kitakyusyu-city,  802,  Japan
      GSK Clinical Trials Call Center, Kitakyusyu-city,  805,  Japan
      GSK Clinical Trials Call Center, Kurume-city,  830,  Japan
      GSK Clinical Trials Call Center, Fukuoka-city,  814,  Japan
      GSK Clinical Trials Call Center, Fukuoka-city,  813,  Japan
      GSK Clinical Trials Call Center, Fukuoka-city,  810,  Japan
      GSK Clinical Trials Call Center, Fukuoka-city,  815,  Japan
      GSK Clinical Trials Call Center, Fukuoka-city,  815,  Japan
      GSK Clinical Trials Call Center, Saga-city,  849,  Japan
      GSK Clinical Trials Call Center, Kanzaki-district,  842,  Japan
      GSK Clinical Trials Call Center, Kikuchi-district,  869,  Japan
      GSK Clinical Trials Call Center, Sakai-city,  590,  Japan
      GSK Clinical Trials Call Center, Sapporo-city,  060,  Japan
      GSK Clinical Trials Call Center, Tokyo,  143,  Japan
      GSK Clinical Trials Call Center, Tokyo,  152,  Japan
      GSK Clinical Trials Call Center, Osaka-city,  532,  Japan
      GSK Clinical Trials Call Center, Osaka-city,  543,  Japan

Study chairs or principal investigators

GSK Clinical Trials, Section manager,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  BRL29060A/856
Last Updated:  August 25, 2005
Record first received:  August 24, 2005
ClinicalTrials.gov Identifier:  NCT00135525
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13