Inflammation and Electroconvulsive Therapy
Does Electroconvulsive Therapy Cause Neuroinflammation? An [18F]FEPPA Positron Emission Tomography Study in Treatment Resistant Depression
調査の概要
状態
条件
詳細な説明
The first scan will take place before the first ECT session. The second scan will occur after a minimum of six ECT sessions (average 2.5 weeks). Secondary measures will include mood symptom severity, neurocognitive measures, peripheral inflammatory markers and TSPO genotype.
The hypothesis is that neuroinflammation will be increased by ECT.
There will be no alterations to standard care of depressed patients due to participation in the study.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ、M5T 1R8
- Centre for Addiction and Mental Health
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- stable physical health
- diagnosis of non-psychotic, non-catatonic, major depressive disorder, either unipolar or bipolar and a non-response to at least three clinical trials at appropriate dose of antidepressant medication from at least three different pharmacological classes
- at least a 17 on the17-item HDRS despite taking antidepressant treatment prior to ECT
- have not received ECT within the last 12 weeks
Exclusion Criteria:
- currently pregnant
- current substance abuse or dependence
- neurological or unstable medical illness
- use of anti-inflammatory drugs within the past month
- diazepam or other benzodiazepine use within the past month, except for lorazepam and clonazepam
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
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
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ECT and Treatment Resistant Depression
Subjects will be those with diagnosis of major depressive disorder that have not responded to many different treatments and who are planning to take electroconvulsive therapy (ECT).
This group will receive two [18F]FEPPA PET scans, one baseline and one after an average of 2.5 weeks of ECT treatments.
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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 |
|---|---|---|
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Change in translocator protein distribution volume (TSPO Vt) measured by [18F]FEPPA PET
時間枠：Baseline scan and a second PET scan after an expected average time of 2.5 weeks of ECT treatment
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Participants will have one [18F]FEPPA PET scan before they start ECT and a second PET scan on average after 2.5 weeks of ECT
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Baseline scan and a second PET scan after an expected average time of 2.5 weeks of ECT treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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17-item Hamilton Depression Rating Scale (HDRS)
時間枠：Baseline and after average 2.5 weeks of ECT treatment
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Scores on the 17-item HDRS will be taken at the time of the PET scan (baseline and post-ECT) to assess whether the magnitude of change in TSPO distribution volume is associated with changes in symptom severity.
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Baseline and after average 2.5 weeks of ECT treatment
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Neurocognitive Battery
時間枠：Baseline and after average 2.5 to 5 weeks of ECT treatment
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Neurocognitive measures will be take at baseline and post-ECT to assess whether TSPO Vt is related to neurocognitive function. Neurocognitive battery includes: Autobiographical Memory Interview-Short Form (AMI-SF) Rey Auditory Verbal Learning Test (RAVLT) Wisconsin Card Sorting Test Comprehensive Trail Making Test Weschler Adult Intelligence Scale-Digit Symbol Subtest Stroop Color and Word Test Brief Visuospatial Memory Test Boston Naming Test Judgement of Line Orientation Weschler Test of Adult Reading |
Baseline and after average 2.5 to 5 weeks of ECT treatment
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Peripheral Inflammatory Markers
時間枠：Baseline and after average 2.5 to 5 weeks of ECT treatment
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To explore whether peripheral and central inflammation are related markers of peripheral inflammation (TNF-alpha, IL-6, CRP and IL-1beta) will be measured and correlated to brain TSPO Vt.
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Baseline and after average 2.5 to 5 weeks of ECT treatment
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協力者と研究者
捜査官
- 主任研究者：Jeffrey H Meyer, MD, PhD、Research Imaging Centre, Centre for Addiction and Mental Health
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
- 074-2012
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
米国で製造され、米国から輸出された製品。
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