NCT00266409已完成4 期
A Multicenter, Randomized, Open-label, Parallel Design Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic 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
- 发起方
- UCB Pharma
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
研究概览
简要总结
An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder. Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI alone during the study. Most symptom evaluations will be done using an automated phone interview system. There are 4 clinic visits.
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
- None
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
- •Must be at least 18 years of age.
- •Diagnosed by the Investigator with primary Generalized Anxiety Disorder (GAD) and/or primary Panic Disorder with or without agoraphobia, either primary episode or recurrence, and is positive for GAD or Panic Disorder by the MHS (Mental Health Screener)).
- •Receiving a new prescription for all SSRI or SNRI as indicated for GAD or Panic Disorder with or without agoraphobia. Definition of a new prescription in case of a recurrence in symptoms is no prescription or refill of prescription of SSRI or SNRI for the past 6 months.
- •Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent.
排除标准
- •Presence of medical condition or presence of schizophrenia, bipolar disorder, alcohol abuse/dependence or any other primary major psychiatric disorder that, in the opinion of the Investigator, would jeopardize the subject or compromise the subject's ability to participate in the trial.
- •Is a current suicide risk in the opinion of the Investigator.
- •Has initiated cognitive therapy within two months of Study Day
- •Does not speak English or does not hear well enough to be able to perform the Hamilton Anxiety (HAM-A) Rating Scale and Mental Health Screener (MHS) by Interactive Voice Response System (IVRS).
- •Has taken a benzodiazepine within the past 30 days.
- •History of hypersensitivity or allergic response to any of the components of SSRIs, SNRIs, benzodiazepines, or related drugs.
- •If a female of child-bearing potential, is pregnant, nursing, or not using appropriate birth control methods.
- •Presence of contraindications to the SSRI or SNRI to be prescribed per the specific package insert.
- •Presence of acute narrow angle glaucoma or taking ketoconazole or itraconazole,which are contraindications to Niravam per the package insert.
- •History of phenylketonuria (PKU).
- •Participation in a previous clinical trial within 30 days prior to Study Day 1.
研究组 & 干预措施
Panic: Niravam+SSRI/SNRI
Experimental
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
干预措施: Niravam (Drug)
Panic: Niravam+SSRI/SNRI
Experimental
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
干预措施: SSRI/SNRI (Drug)
Panic: SSRI/SNRI alone
Experimental
Panic Disorder: Newly prescribed SSRI or SNRI alone
干预措施: SSRI/SNRI (Drug)
GAD: Niravam+SSRI/SNRI
Experimental
Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI
干预措施: Niravam (Drug)
GAD: Niravam+SSRI/SNRI
Experimental
Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI
干预措施: SSRI/SNRI (Drug)
GAD: SSRI/SNRI alone
Experimental
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
干预措施: SSRI/SNRI (Drug)
结局指标
主要结局
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
时间窗: 10 weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
时间窗: 10 weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
次要结局
- Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks(2 weeks)
- Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks(3 weeks)
- Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks(4 weeks)
- Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks(5 weeks)
- Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks(6 weeks)
- Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks(7 weeks)
- Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks(8 weeks)
- Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period(at endpoint during the 8 week treatment period)
- Change From Baseline in the Total HAM-A Score After 1 Week(Baseline and 1 week)
- Change From Baseline in the Total HAM-A Score After 2 Weeks(Baseline and 2 Weeks)
- Change From Baseline in the Total HAM-A Score After 3 Weeks(Baseline and 3 weeks)
- Change From Baseline in the Total HAM-A Score After 4 Weeks(Baseline and 4 weeks)
- Change From Baseline in the Total HAM-A Score After 5 Weeks(Baseline and 5 weeks)
- Change From Baseline in the Total HAM-A Score After 6 Weeks(Baseline and 6 weeks)
- Change From Baseline in the Total HAM-A Score After 7 Weeks(Baseline and 7 weeks)
- Change From Baseline in the Total HAM-A Score After 8 Weeks(Baseline and 8 weeks)
- Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period(Baseline and at endpoint during the 8 week treatment period)
- Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week(1 week)
- Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks(2 weeks)
- Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks(3 weeks)
- Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks(4 weeks)
- Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks(5 weeks)
- Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks(6 weeks)
- Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks(7 weeks)
- Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks(8 weeks)
- Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period(at endpoint during the 8 week treatment period)
- Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks(Baseline and 2 weeks)
- Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks(Baseline and 4 weeks)
- Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks(Baseline and 8 weeks)
- Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period(Baseline and at endpoint during the 8 week treatment period)
- Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week(1 week)
- Change From Baseline in HAM-A-insomnia Subscore After 1 Week(Baseline and 1 week)
- Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks(Baseline and 2 weeks)
- Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks(Baseline and 3 weeks)
- Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks(Baseline and 4 weeks)
- Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks(Baseline and 5 weeks)
- Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks(Baseline and 6 weeks)
- Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks(Baseline and 7 weeks)
- Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks(Baseline and 8 weeks)
- Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period(Baseline and at endpoint during the 8 week treatment period)
- Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week(Baseline and 1 week)
- Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks(Baseline and 2 weeks)
- Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks(Baseline and 3 weeks)
- Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks(Baseline and 4 weeks)
- Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks(Baseline and 5 weeks)
- Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks(Baseline and 6 weeks)
- Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks(Baseline and 7 weeks)
- Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks(Baseline and 8 weeks)
- Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period(Baseline and at endpoint during the 8 week treatment period)
- Change From Baseline in HAM-A-somatic Subscore After 1 Week(Baseline and 1 week)
- Change From Baseline in HAM-A-somatic Subscore After 2 Weeks(Baseline and 2 weeks)
- Change From Baseline in HAM-A-somatic Subscore After 3 Weeks(Baseline and 3 weeks)
- Change From Baseline in HAM-A-somatic Subscore After 4 Weeks(Baseline and 4 weeks)
- Change From Baseline in HAM-A-somatic Subscore After 5 Weeks(Baseline and 5 weeks)
- Change From Baseline in HAM-A-somatic Subscore After 6 Weeks(Baseline and 6 weeks)
- Change From Baseline in HAM-A-somatic Subscore After 7 Weeks(Baseline and 7 weeks)
- Change From Baseline in HAM-A-somatic Subscore After 8 Weeks(Baseline and 8 weeks)
- Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period(Baseline and at endpoint during the 8 week treatment period)
- Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week(1 week)
- Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks(2 weeks)
- Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks(3 weeks)
- Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks(4 weeks)
- Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks(5 weeks)
- Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks(6 weeks)
- Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks(7 weeks)
- Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks(8 weeks)
- Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period(at endpoint during the 8 week treatment period)
研究者
研究点 (1)
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