EUCTR2014-003080-38-GB进行中（未招募）1 期
Glutamatergic Medication in the Treatment of Obsessive-Compulsive Disorder (OCD) and Autism Spectrum Disorder (ASD) - GOAT (Glutamatergic OCD&ASD Treatments)
Radboud University, Nijmegen Medical Centre, Donders Institute for Brain, Cognition and Behaviour0 个研究点目标入组 100 人开始时间: 2017年2月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients
- •Inpatient or outpatient status
- •Aged 6;0 y. (ASD patients) / 8;0 y. (OCD patients) - 17.9 years at initial inclusion
- •IQ = 70 (if an IQ-test was not done within 2 y from Baseline visit, the IQ assessment should be based on Wechsler scales, 4 subtests, cf. 5.1.3)
- •CGI-S score >/= 4 (moderately ill; anchored to respective disorder) at Baseline (BL, visit 3)
- •Ability to speak and comprehend the native language of the country in which the assessments take place
- •Signed informed consent by parents or legal representative
- •Signed informed assent by patients (indicating that the subject is aware of the investigational nature and the core aspects of the study and the study is run in accordance with the ICH GCP guideline E6 (1996))
- •Female subject must not have a positive beta HCG pregnancy test at screening, and must have a negative urine pregnancy test at baseline (BL), and agree to comply with applicable contraceptive requirements
- •Inclusion criteria for subjects with OCD (GOAT_1): DSM-5 diagnosis of OCD (APA, 2013), according to a systematic interview, e.g., DISC interview, k-SADS
- •Inclusion criteria for subjects with ASD (GOAT_2): DSM-5 diagnosis of ASD (APA, 2013), according to ADI-R interview (shortened version, focusing on criteria for diagnostic decision)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 26
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Mental retardation (IQ < 70)
- •Body weight < 20kg at baseline (BL)
- •Major physical illness of the cardiovascular, endocrine, pulmonary, or the gastrointestinal system
- •Contra-indications for memantine, according to the Summary of Product characteristics (SPC)
- •History of or present clinically relevant somatic acute or chronic disorder that, in the opinion of the investigator, might confound the results of olerability/safety assessment, or prohibit the patients from completing the study, or would not be in the best interest of the patient.
- •Subject has failed to respond, based on investigator judgement, to an earlier adequate course (dose and duration) of the investigational drug therapy, memantine.
- •Subject has a documented allergy, hypersensitivity, or intolerance to memantine.
- •Subject has a lactose intolerance.
- •Subject has a positive urine drug screen result at screening or BL (apart from earlier prescribed medication; retest and negative result at BL needed then)
- •Subject has taken another investigational product or taken part in a clinical study with 30 days prior to screening
- •Subject is female and is pregnant or lactating
- •For those subjects intending to participate in the neuroimaging assessments: All contra indications for MRI assessment, such as the presence of metal objects in or around the body (pacemaker, dental braces)
- •Patients/parents will not be excluded from the study(ies) in case they do not agree to participate in certain sets of assessments (e.g., neuroimaging, blood sampling for bioanalytical analyses).
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