AMEND - Add-on MEmaNtine to Dopamine modulation to improve negative symptoms at first psychosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Primary Endpoints Primary endpoint will be reduction in negative symptoms as measured with Positive and Negative Syndrome Scale (PANSS) negative symptoms after 12 weeks of treatment [PANSS negative baseline - PANSS negative at week 12]. Assessments will be supplemented by Brief Negative Symptom Scale (BNSS) scores.
研究概览
简要总结
Antipsychotics affects the brain's dopamine system, and the drugs reduce delusions, hallucinations, and disorganized thinking, which are cardinal symptoms of psychotic disorders. However, negative symptoms e.g. anhedonia, avolition, and social withdrawal, as well as cognitive deficits, are not sufficiently treated. Memantine is used to treat Alzheimer's disease and affects the brain's glutamate system. AMEND is a 12-week, double-blind, placebo controlled, randomized clinical trial (RCT) testing effects of add-on memantine to initial antipsychotic treatment in patients with first episode psychosis. The main aim is to reduce negative symptoms.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Antipsychotic-free (as defined under Exclusion Criteria below), first episode psychosis
- •Fulfilling the diagnostic criteria of schizophrenia, persistent delusional disorder, acute and transient psychotic disorders, schizoaffective disorder, other non-organic psychotic disorders and unspecified non-organic disorders (ICD-10: F20.x; F22.x; F23.x; F24.x; F25.x; F28; F29); verified by PSE interview.
- •Age: 18-45 years
- •Legally competent (In Danish: ‘myndige og habile i retslig forstand’)
排除标准
- •Prior use of antipsychotic medication longer than an episode of two weeks in the previous year and/or 6 weeks lifetime, and/or antipsychotic treatment within 30 days prior to inclusion.
- •Pregnancy (assessed by urine HCG)
- •Female patients: Unwillingness to use safe contraception (Intra Uterine Device/System or hormonal contraceptives) during the study period.
- •Severe physical illness
- •Allergies to any of the ingredients in the aripiprazole tablets or memantine tablets
- •Refusing to receive information about incidental findings on MRI
- •Treatment with antidepressant medication the last 7 days
- •Current substance dependence ICD-10 (F1x.2) or substance abuse in any period up to 3 months prior to referral (exception: tobacco/nicotine, F17.2)
- •Head injury with more than 5 minutes of unconsciousness, lifetime
- •Any coercive measure
- •Metal implanted by operation
- •Tattoos/permanent makeup drawn before the year of 2000 or outside of approved tattoo studio (EU standards)
- •Tattoos placed within 48 hours
- •Excessive tattoos /whole body parts tattoos (assessed upon inclusion)
结局指标
主要结局
Primary Endpoints Primary endpoint will be reduction in negative symptoms as measured with Positive and Negative Syndrome Scale (PANSS) negative symptoms after 12 weeks of treatment [PANSS negative baseline - PANSS negative at week 12]. Assessments will be supplemented by Brief Negative Symptom Scale (BNSS) scores.
Primary Endpoints Primary endpoint will be reduction in negative symptoms as measured with Positive and Negative Syndrome Scale (PANSS) negative symptoms after 12 weeks of treatment [PANSS negative baseline - PANSS negative at week 12]. Assessments will be supplemented by Brief Negative Symptom Scale (BNSS) scores.
次要结局
- changes in cognition (in particular working memory, set-shifting, and attention)
- Change in PANSS positive and PANSS total
- clinical measures, level of functioning, side effects
- glutamate levels in five a priori selected regions: thalamus, anterior cingulate cortex (ACC), hippocampus, dorsolateral prefrontal cortex (DLPFC), and basal ganglia.
- Exploratory endpoints include associations between clinical data, quality of life, brain metabolites in other regions, e.g. ACC, and structural measures (e.g. hippocampus subfields), and basal ganglia quantification (See Table 1 for detailed assessments). Interactions between baseline brain metabolite levels and brain structure in patients and HC will also be investigated.
研究者
Bjørn Ebdrup
Scientific
Region Hovedstadens Psykiatriske