Dissecting Immunological and Autoimmune Mechanisms of Neuropsychiatric Diseases (DIAMOND)
The goal of this observational cohort study is to investigate the role of immune system in neuropsychiatric symptoms (NPS) and to identify immunological biomarkers that may improve the diagnosis, prognosis, and future treatment of immune-related neuropsychiatric disorders in individuals aged 16-100 years with suspected immune-mediated neuropsychiatric symptoms and matched control participants without neuropsychiatric symptoms.
The main questions it aims to answer are what immunological mechanisms are associated with neuropsychiatric symptoms across a range of neurological, psychiatric, autoimmune, infectious, and inflammatory conditions. Also, if immunological biomarkers can be identified that may support the diagnosis, prognosis, and future treatment of neuropsychiatric disorders in which the immune system may play a role.
Participants will provide a blood sample for immunological analysis and may optionally provide a cerebrospinal fluid (CSF) sample if a suitable previously collected sample is not available. Researchers may also analyse existing clinical and biological samples where available. Participants will provide demographic and clinical information, allow access to relevant medical record data, and may optionally provide additional blood samples, up to four times within one year, for further biomarker and immunological analyses.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
-
London、イギリス、SE5 9RS
- King's College Hospital
-
London、イギリス、SE5 8AB
- South London and Maudsley NHS Foundation Trust
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
INCLUSION CRITERIA
Participants with Neuropsychiatric symptoms
- Age 16-100.
- Current or previous neuropsychiatric symptoms within the last year.
- Suspicion of immunological contribution to the aetiology of their neuropsychiatric symptoms.
Control Participants
- Age 16-100.
- No current or previous self-report of neuropsychiatric symptoms within the last year.
Optional Lumbar Puncture only:
- Documented full blood count within the last 3 months with no clinically significant abnormalities.
EXCLUSION CRITERIA
All Participants:
- Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.
- Inability to have blood tests.
Optional Lumbar Puncture only:
- Significant lower spinal deformity (such as spina bifida), injury, or disease (such as stenosis) or previous lower spinal surgery.
- Antiplatelet or anticoagulant therapy within the 14 days prior to Lumbar Puncture procedure.
- Known or suspected clotting disorder.
- Clinically significant abnormality in full blood count.
- Known or suspected raised intracranial pressure, assessed by study clinician.
- Known or suspected allergy to local anaesthetic agent or an ingredient of the anaesthetic solution.
- History of chronic or recurrent headaches, in the opinion of the investigator.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
コントロール参加者
|
|
Participants with neuropsychiatric symptoms
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neuronal Autoantibodies
時間枠：From enrolment through to 1 year of follow-up.
|
Differences in the prevalence, subtype, and functional characteristics of neuronal autoantibodies in serum and cerebrospinal fluid between participants with neuropsychiatric symptoms (NPS) and matched control participants.
|
From enrolment through to 1 year of follow-up.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 354922
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。