2024-514585-39-00已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Improvement in obsessive-compulsive symptomatology is assessed using the Y-BOCS change from baseline in the total score.
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of troriluzole as adjunctive therapy compared to placebo in subjects with OCD who have had an inadequate response to their current OCD treatment based on the change in their Y-BOCS score.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subject's illness must be ≥ 1 year.
- •Subjects must be currently experiencing non-response or inadequate response to their current SOC medication defined as: Subjects Y-BOCS total score must be ≥ 22 at Screening and Baseline, reflecting moderate or severe OCD symptoms.
- •Subjects must currently be on an SSRI (with the exception of fluvoxamine, see Section 1.1.3), or clomipramine, venlafaxine or desvenlafaxine monotherapy treatment for an adequate duration and at an adequate dose defined as clinical trial protocol.
排除标准
- •Subjects with a history of more than two (2) previous failed or inadequate treatment trials of SSRIs, clomipramine, venlafaxine, or desvenlafaxine, (not including the current SSRI trial) given for an adequate duration at an adequate dose.
- •Subjects should be excluded at screening or baseline if any medical or psychiatric condition other than OCD, as specified in the inclusion criteria, could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of OCD symptoms.
- •Current or prior history, per DSM-5 criteria, of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, but a primary diagnosis of hoarding disorder is excluded); a current diagnosis of Tourette's disorder is also excluded.
结局指标
主要结局
Improvement in obsessive-compulsive symptomatology is assessed using the Y-BOCS change from baseline in the total score.
Improvement in obsessive-compulsive symptomatology is assessed using the Y-BOCS change from baseline in the total score.
次要结局
- The change from baseline on the SDS total score and the CGI Severity score.
研究者
Clinical Trial Lead
Scientific
Biohaven Pharmaceuticals Inc.
研究点 (9)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis (ADhere-J)Atopic DermatitisJPRN-jRCT2031200389Masaki Takeshi280
已完成
不适用
A clinical study to evaluate the efficacy and safety of Turmeric Capsules (TurmXtra 60 N) Delayed onset muscle soreness in healthy recreationally active subjectsCTRI/2021/12/038892Inventia Healthcare Ltd30
招募中
1 期
A research study investigating troriluzole as a possible treatment for Obsessive Compulsive DisorderCTIS2024-514585-39-00Biohaven Pharmaceuticals Inc.700
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFRCentral neuropathic pain due to Multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic painEUCTR2008-002560-34-BEEli Lilly and Company238
已完成
4 期
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of GUT RESET Capsules in Alleviating the Gastro-Esophageal Reflux (GER)-Related SymptomsCTRI/2023/11/059857Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.)50