The Supplementation Therapy in Autism and Response to Treatment (START) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Symptom-Checklist-90-R
研究概览
简要总结
In addition to the "core" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is estimated that up to 70% of autistic people present at least one comorbid psychiatric disorder, leading to a deterioration in quality of life, a greater demand for support and worse prognosis and outcome. Anxiety and depressive symptoms would seem to be more present in individuals with Level 1 ASD, requiring their prioritisation against core symptoms. To date, the first-line treatment for autistic patients with comorbid depressive and/or anxiety symptoms is still debated and it is not always clear whether they may or may not benefit from psychotherapeutic and conventional psychopharmacological approaches. As such, growing evidence strengthens the therapeutic potential of the endocannabinoid (eCB) system modulation and of eCB-like compounds.
The aim of this study is to provide a response to an unmet clinical need in this framework of psychic vulnerability by initiating oral therapy with palmitoylethanolamide (PEA), a nutraceutical/food supplement with proven anti-inflammatory and neuroprotective properties.
Indeed, many conditions of psychological distress are thought to be underpinned by systemic inflammatory and/or neuroinflammatory processes, on which PEA has shown remarkable efficacy, including through modulation of the immune response and the interaction between the endocannabinoid system and the gut-microbiota-brain axis.
The trial we are proposing is a 12-week open-label phase 2 study involving the daily intake of PEA 600 mg, at a dosage of 1 tablet/day.
This study will be conducted at the Unit of Psychiatry of Santa Maria della Misericordia Udine University Hospital.
Through this study, we wish to evaluate: the ability of PEA to alleviate symptoms of psychic distress (i.e., anxiety and/or depression) in Level 1 autistic adults; the safety and tolerability of sustained intake of PEA in Level 1 autistic adults; and the biological basis of PEA functioning.
The study involves taking PEA orally once daily (600 mg daily) at the same time as a meal during the initial 12-week phase. Upon completion of the initial phase, subjects will be offered to enter an extension phase of the trial of an additional 24 weeks to assess treatment stability, with the possibility of titration of PEA to 1200 mg daily based on observed clinical compensation. Each participant will be on PEA treatment for up to 36 weeks.
During the course of the study, periodic clinical re-evaluations will be conducted at our Day-Hospital setting.
The trial will unfold through one screening visit, one baseline visit, and two follow-up visits (FUP, 4 weeks and 12 weeks apart). The patient will be administered standardized interviews by a qualified investigating physician; clinical objective examination, collection of blood and urine samples for standard hematochemical investigations, collection of blood and stool samples for analysis of some biological markers of interest, monitoring of adherence to therapy intake, side effects, and adverse effects will also be performed during the follow-up visits. The nutraceutical PEA will be dispensed by the clinical investigators at each follow-up visit.
详细描述
- RATIONALE FOR CURRENT STUDY
The main purpose of the present study is to address a major unmet clinical need for Level 1 autistic individuals with comorbid anxiety and/or depressive symptoms, with respect to a condition of psychic vulnerability not responding to conventional psychopharmacological approaches. We will thus perform an investigator-initiated proof-of-concept study (Phase-2 Pilot Study), with the purpose to examine:
(i) Palmitoylethanolamide (PEA) ability to alleviate symptoms of psychic distress (i.e., anxiety and/or depression) in Level 1 autistic individuals; (ii) PEA safety and tolerability; (iii) The biological basis of PEA effect. 2. TRIAL OBJECTIVES
To evaluate:
(i) The viability of identifying and consenting Level 1 autistic volunteers into a trial with PEA; (ii) The efficacy of PEA in providing relief to anxiety and/or depressive symptoms in Level 1 autistic individuals; (iii) Whether sustained PEA treatment is well tolerated by Level 1 autistic individuals over a period of at least 12 weeks; (iv) The biological mechanisms underpinning PEA beneficial effects in Level 1 autistic individuals (e.g., modulation of the endocannabinoid (eCB) system, immunological response, metabolic fingerprinting, gut microbiome composition).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with Level 1 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5);
- •Aged 18-35 years;
- •To be able to understand and communicate in Italian;
- •To be able to give informed consent.
排除标准
- •Level 2 or Level 3 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) [47];
- •Current diagnosis of a co-occurring major psychiatric disorder (e.g., major depressive disorder, bipolar affective disorder, psychotic disorders);
- •Active suicidal ideation indicating significant current risk or history of serious suicide attempt in the opinion of the PI, as evaluated at the screening stage;
- •Lifetime neurological disorders (e.g., epilepsy, except febrile convulsions) or severe intercurrent physical illness;
- •Current treatment with psychotropic medication, with the exception of Selective Serotonin Reuptake Inhibitor (SSRI) stable monotherapy (at least 8 months);
- •IQ < 70;
- •Female patients who are pregnant, lactating or not using an acceptable effective form contraception if they are at risk of falling pregnant;
- •Taking part in another pharmacological trial.
结局指标
主要结局
Symptom-Checklist-90-R
时间窗: 12 weeks for the initial phase, further 24 weeks for the extension phase
Global improvement in symptom intensity and psychological distress associated with autism through the Global Score Index (GSI) of the SCL-90-R
次要结局
- Hospital Anxiety and Depression Scale(12 weeks for the initial phase, further 24 weeks for the extension phase)
- Symptom-Checklist-90-R(12 weeks for the initial phase, further 24 weeks for the extension phase)
- World Health Organization Disability Assessment Schedule 2.0(12 weeks for the initial phase, further 24 weeks for the extension phase)