Status:
COMPLETED
Study Of Generalized Anxiety Disorder
Lead Sponsor:
GlaxoSmithKline
Conditions:
Anxiety Disorder
Anxiety Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 1...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00135525
Start Date
May 1 2003
End Date
May 1 2006
Last Update
January 31 2011
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