A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment
概览
- 阶段
- 2 期
- 干预措施
- ITI-1284 10 mg
- 疾病 / 适应症
- Generalized Anxiety Disorder
- 发起方
- Intra-Cellular Therapies, Inc.
- 入组人数
- 570
- 试验地点
- 62
- 主要终点
- Hamilton Anxiety Rating Scale (HAM-A)
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.
详细描述
The study will be conducted in 3 periods: * Screening Period (up to 2 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur; * Double-blind Treatment Period (6 weeks) during which a total of approximately 570 patients are planned to be randomized in a 1:1:1 ratio to receive one of the 3 treatments (ITI-1284 10 mg, ITI-1284 20 mg, or placebo); * Safety Follow-up Period (1 week) during which all patients will return for a safety follow-up visit approximately 1 week after the last dose of study drug.
研究者
入排标准
入选标准
- •Provide written informed consent before the initiation of any study specific procedures;
- •At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:
- •HAM-A Total score of ≥ 22;
- •HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
- •CGI-S score of ≥ 4;
- •History of inadequate response (\< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire \[ATRQ\] for GAD) to at least 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least the minimum GAD-approved dose per package insert) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms.
排除标准
- •Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:
- •Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- •Bipolar Disorder;
- •MADRS total score \> 18 at Screening or Baseline;
- •In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
- •At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
- •At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
- •At Screening or Baseline MADRS Item 10 score ≥ 5; or
- •The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator;
- •Lifetime history of failure to respond to \> 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (ie, at least the minimum dose approved for GAD per package insert) and for an adequate duration (ie, at least 6 weeks).
研究组 & 干预措施
ITI-1284 10mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
干预措施: ITI-1284 10 mg
ITI-1284 20mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
干预措施: ITI-1284 20 mg
Placebo
Matching placebo tablet, taken once daily, sublingual administration
干预措施: Placebo
结局指标
主要结局
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: Week 6
The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). It is comprised of 14 items that are rated on a 5-point scale ranging from 0
次要结局
- Clinical Global Impression Scale-Severity (CGI-S)(Week 6)