Clinical Evaluation of BRL29060 A in Generalized Anxiety Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 主要终点
- Mean change from baseline in the Hamilton Anxiety Scale (HAM-A) total score (at Week 8, last observation carried forward [LOCF])
研究概览
简要总结
This study is designed to evaluate the efficacy and safety in Generalized Anxiety Disorder patients
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Paroxetine
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.
干预措施: Paroxetine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline in the Hamilton Anxiety Scale (HAM-A) total score (at Week 8, last observation carried forward [LOCF])
时间窗: 8 Weeks
次要结局
- 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(8 Weeks)