Clinical trial NCT00135525: Study Of Generalized Anxiety Disorder
Official title: Clinical Evaluation of BRL29060 A in Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety Disorder
Anxiety Disorders
Keywords: Generalized Anxiety Disorder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Mean change from baseline in the Hamilton Anxiety Scale (HAM-A) total score (at Week 8, last observation carried forward [LOCF])
timeFrame: 8 Weeks
Secondary outcomes:
measure: Mean change from baseline in the HAM-A score (at Weeks 1, 2, 4 and 6); in the Severity of Illness (CGI SI) score; in the SDS and MADRS total scoreProportion of responders based on the Clinical Global Impression Global Improvement (CGI GI) score
timeFrame: 8 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: