NCT01118780已完成4 期
Duloxetine Versus Placebo in the Treatment of Elderly Patients With Generalized Anxiety Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) Total Score
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of duloxetine versus placebo in elderly patients suffering from generalized anxiety disorder (GAD).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have GAD based on diagnostic criteria and not suffer from an adjustment disorder or anxiety disorder not otherwise specified. Symptoms of GAD should not be situational in nature.
- •Have a Mini Mental State Examination (MMSE) score of at least 24 at screening.
- •Have a Clinical Global Impressions of Severity (CGI-Severity) score of greater than or equal to 4 at screening and randomization.
- •Have a Covi Anxiety Scale (CAS) score of greater than or equal to 9, no item in the Raskin Depression Scale (RDS) may be >3, and the CAS score must be greater than the RDS at screening.
- •Have a Hospital Anxiety and Depression Scale (HADS) anxiety subscale score of greater than or equal to 10 at screening.
- •Have a degree of understanding such that the participant can communicate intelligibly with the investigator and study coordinator.
- •Are judged to be reliable to keep all appointments and able to swallow all required medication without opening or crushing.
排除标准
- •Have any current and primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revised (DSM-IV TR) Axis I diagnosis other than GAD, with the exception of comorbid social phobia or specific phobia.
- •major depressive disorder (MDD) within the past 6 months, or
- •panic disorder, posttraumatic stress disorder (PTSD), or an eating disorder within the past year, or
- •obsessive compulsive disorder (OCD), bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders during their lifetime.
- •The presence of an Axis II disorder, or history of antisocial behavior, or participants who, in the opinion of the investigator, are poor medical or psychiatric risks for study compliance.
- •Have organic mental disorder or mental retardation diagnosis.
- •Use of benzodiazepine within 14 days prior to randomization.
- •Are judged clinically to be at serious risk of harm to self or others.
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine within the past year or participants with a lack of response or intolerability to duloxetine (for any approved indication) at a clinically appropriate dose for a minimum of 4 weeks.
- •Have a history of alcohol or any psychoactive substance abuse or dependence within the past 6 months.
- •Excessively use caffeine, in the opinion of the investigator.
- •Have a positive urine drug screen (UDS) for any substances of abuse at screening.
- •Have a serious medical illness.
- •Have any acute liver injury or severe cirrhosis.
- •Have an abnormal thyroid-stimulating hormone (TSH) concentrations.
- •Have initiated psychotherapy or changed intensity of psychotherapy or other non-drug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or at any time during the study.
- •Have taken any excluded medication within 7 days prior to randomization.
- •Have been treated with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of randomization or potentially need to use an MAOI during the study or within 5 days of discontinuation of study drug.
- •Exhibit a lack of response of the current episode of GAD to 2 or more adequate trials of antidepressants, benzodiazepines, or other anxiolytics at a clinically appropriate dose for a minimum of 4 weeks.
- •Have a history of severe allergies, hypersensitivity to duloxetine or to any of the inactive ingredients; multiple adverse drug reactions; transcranial magnetic stimulation (TMS); history of seizures; or history of psychosurgery or electroconvulsive therapy (ECT) within 12 months.
- •Have discontinued hormone replacement therapy within the previous 3 months.
- •Have uncontrolled narrow-angle glaucoma.
研究组 & 干预措施
Duloxetine 30 milligrams (mg) -120 mg
Experimental
干预措施: Duloxetine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) Total Score
时间窗: Baseline, Week 10
The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.
次要结局
- Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Global Functional Impairment Score(Baseline, Week 10)
- Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) (Psychic Anxiety Factor Score, Somatic Anxiety Factor Score, and Individual Item Scores: Anxious Mood Item and Tension Item)(Baseline, Week 10)
- Change From Baseline to Week 10 Endpoint in Hospital Anxiety Depression Scale (HADS) Subscale Scores(Baseline, Week 10)
- Clinical Global Impressions of Improvement Scale (CGI-Improvement) at Week 10(Week 10)
- Patient's Global Impressions of Improvement Scale (PGI-Improvement) at Week 10(Week 10)
- Change From Baseline to Week 10 in Brief Pain Inventory-Modified Short Form (BPI-SF) Pain Severity and Interference Subscales(Baseline, Week 10)
- Change From Baseline to Week 10 in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Score(Baseline, Week 10)
- Number of Participants With Treatment-Emergent Suicide-Related Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline through 10 weeks)
- Percentage of Participants With Sustained Improvement (Sustained Improvement Rate)((Baseline through 10 weeks) and (Baseline, Week 2 through Week 10))
- Adverse Events (AEs) Leading to Discontinuation From Study(Baseline through 10 weeks)
- Percentage of Participants Reporting Falling Down(Baseline through 10 weeks)
- Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Work/School, Social Life, and Family/Home Management Individual Impairment Scores(Baseline, Week 10)
- Percentage of Participants With Response or Remission at Week 10 (Response and Remission Rates)(Baseline, Week 10)
- Percentage of Participants With Functional Remission at Week 10 (Functional Remission Rate)(Week 10)
- Time to First Response(Baseline through 10 weeks)
- Time to First Remission(Baseline through 10 weeks)
- Time to Sustained Improvement Overall(Baseline through 10 weeks)
- Time to First Functional Remission(Baseline through 10 weeks)
- Time to First Improvement(Baseline through 10 weeks)
研究者
研究点 (1)
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