Study Of Generalized Anxiety Disorder

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Anxiety Disorder; Anxiety Disorders

Treatments: Drug: Paroxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00135525

BRL29060A/856

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Paroxetine

Experimental group

Description:

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.

Treatment:

Drug: Paroxetine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo