Study Of Generalized Anxiety Disorder
Anxiety Disorder, Anxiety Disorders
About this trial
This is an interventional treatment trial for Anxiety Disorder focused on measuring Generalized Anxiety Disorder
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Paroxetine
Placebo
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.