NL-OMON53842已完成不适用
Exploring biological measures to facilitate the discovery and development of new treatments for social and cognitive deficits in Alzheimer*s disease, schizophrenia, and major depression: replication and generalisability of the Psychiatric Ratings using Intermediate Stratified Markers (PRISM)1 study - PRISM2
Gregorio Marañón Hospital0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria (MDD, SZ and AD populations)
- •- Provision of signed and dated informed consent form (ICF) from patient prior
- •to any study-specific procedures being performed.
- •- The patient should have a reliable study partner with whom he/she cohabits or
- •has regular contact with, who gives consent to participate in the study and
- •provide study data (limited to the Neuropsychiatric Inventory for AD patients
- •and the WHO Disability Asessment Schedule (WHODAS) for AD, SZ and MDD patients).
- •- Not socially withdrawn due to external circumstances (e.g. lack of access to
- •transport, rural location) or comorbid medical disorder or disability (e.g.,
- •hearing loss, lack of mobility, facial disfigurement).
- •- Patient and study partner must be able to read, write, and speak the language
- •in which assessments are provided.
- •- Unless otherwise stated central nervous system (CNS) medications to treat
- •cognitive impairment due to AD, symptoms of SZ or MDD, and other stable CNS
- •conditions requiring such medication, are permitted provided the patient has
- •been maintained on a stable dose regimen for at least 8 weeks before start of
- •the study, and they are expected to continue this treatment in a stable manner
- •during the current study. Similarly, psychological treatments (e.g., Cognitive
- •Behaviour Therapy, Interpersonal Psychotherapy, Psychodynamic Psychotherapy
- •etc.) are all permitted in this study regardless of frequency and duration, so
- •long as this treatment is expected to remain stable during the duration of the
- •- Patient is right-handed or ambidextrous. In the case of ambiguity the
- •Edinburgh Handedness Inventory will be used to determine handedness.
- •Additional inclusion Criteria - AD participants
- •- Men and women aged 50 to 80 years (inclusive).
- •- Probable AD, meeting the National Institute on Aging (NIA) and the
- •Alzheimer*s Association (AA) (NIA-AA) criteria for probable AD
- •- Mini-Mental State Examination (MMSE) score of 20 to 26, inclusive.
- •Additional inclusion Criteria - SZ participants
- •- Patients are male or female, 18-45 years of age (inclusive) with an
- •established diagnosis of schizophrenia according to medical history.
- •- If the patient uses any antipsychotic, anticholinergic or antidepressant
- •medication, dosage needs to be stable for at least 8 weeks prior to the study
- •- A DSM-IV diagnosis of SZ with at least one confirmed psychotic episode but
- •not longer than 15 years of disease duration (since first date of established
- •SZ clinical diagnosis). It is, however, preferred and actively encouraged to
- •include patients with a maximum disease duration of 10 years.
- •Additional inclusion Criteria - MDD participants
- •- Male or female, aged 18-55 years of age, inclusive. It is, however, preferred
- •and actively encouraged to include patients aged 45 years and under.
- •- Have a primary Diagnostic and Statistical Manual of Mental Disorders 4th
- •edition (DSM-IV) diagnosis of MDD without psychotic features, as confirmed by
- •medical history. Subjects with a diagnosis of comorbid Generalized Anxiety
- •Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder, insomnia or
- •specific phobia may be included.
- •- Meet the DSM-IV criteria for a current Major Depressive Episode.
- •Additional inclusion Criteria - HC participants
- •- Men and women, aged 18-80, inclusive (of s
排除标准
- •Exclusion criteria (MDD, SZ and AD populations)
- •Patients cannot enter the study if any of the following exclusion criteria are
- •- Significant neurological disease affecting the CNS, other than AD, SZ, or MDD
- •(e.g. other dementias, serious infection of the brain, Parkinson*s disease,
- •epilepsy) as documented in the patient*s medical file which in the judgement of
- •the investigator may affect the patient's ability to complete the study
- •assessments.
- •- Any other current psychiatric diagnosis, including personality disorders,
- •requiring intervention other than AD, SZ, and MDD according to medical history
- •that in the judgement of the investigator may affect the patient's ability to
- •complete the study assessments.
- •- Current serious or unstable clinically important systemic illness (e.g.
- •hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic,
- •immunologic, hematologic, or ocular disorders) that in the judgement of the
- •investigator may affect the patient's ability to complete the study assessments.
- •- History of chronic alcohol or drug abuse or dependence within the previous 3
- •- Participated in any investigational study to treat either AD, SZ, or MDD
- •symptoms or has taken an investigational drug within 90 days (or 5 times the
- •half-life of the investigational drug, whichever is longer). In addition, if
- •they have participated in two or more studies with an experimental drug within
- •5 months prior to screening.
- •- In the investigator*s judgement is medically non-compliant in the management
- •of their disease.
- •- Has within 6 weeks prior to the first assessment visit been prescribed a
- •medication that may affect the CNS that in the judgment of the investigator may
- •interfere with the patient's ability to complete the study assessments.
- •- Has any contraindications for MRI studies, including claustrophobia, the
- •presence of metal (ferromagnetic) implants, pregnancy, or cardiac pacemaker
- •that is not compatible with MRI scanning.
- •- Are, in the opinion of the investigator, likely to present a danger to
- •themselves or others or where the severity of the illness precludes them from
- •completing the study procedures. In the case of high suicidality scores on the
- •QIDS, the study researcher will contact the person who referred the participant
- •to the study.
- •Additional exclusion Criteria - AD participants
- •- Multiple strokes based on history and/or imaging results
- •- A score of 4 or greater on the global Parkinsonism item of the Extrapyramidal
- •Symptom Rating Scale (ESRS) (only relevant to those patients currently taking
- •an antipsychotic medication).
- •- QIDS-SR16 score of >= 16
- •Additional exclusion Criteria - SZ participants
- •Patients will be excluded from the study if they meet any of the following
- •- A score of 22 or more on the sum of the 7 PANSS (The Positive and Negative
- •Syndrome Scale) positive symptom factor items. The score of the items of P1
- •(delusions), P3 (hallucinatory behaviour), P6 (suspiciousness) and G9 (unusual
- •thought content) meet the following requirements:
- •- No more than 2 of the above items have a score of 4.
- •- All of the above items score less than 5.
- •- In the clinician*s judgment, patients who, for any reason, are considered to
- •be a danger to themselves.
- 另有 2 项未显示
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