Study Of Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Paroxetine

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.