Estimation of Control Before and After Treatment of a Depressive Episode With Serotonin Reuptake Inhibitors (APTE-Sero)
調査の概要
状態
条件
詳細な説明
The main questions it aims to answer are:
How do individuals with a depressive episode differ from healthy controls in their estimation of control over environmental events? How does antidepressant treatment (selective serotonin reuptake inhibitors) influence perceived control, cognitive performance, and depressive symptoms over time? Are changes in perceived control and symptoms associated with biological markers measured during the study?
Researchers will compare participants with a current depressive episode to healthy control participants, and examine changes over time in the depressed group before and after treatment initiation, in order to assess the effects of antidepressant treatment on cognition, perceived control, and symptoms.
Participants will:
- Complete 4 study sessions over approximately 8 weeks, including 2 in-person visits at the Centre de Recherche en Neurosciences de Lyon (CRNL) and 2 online sessions.
- Complete questionnaires assessing depressive symptoms, personality traits, and life events.
- Perform computerized behavioral tasks involving prediction, learning, memory, and decision-making in virtual environments.
- Complete tasks designed to assess perceived control over outcomes in different contexts.
- Undergo non-invasive physiological recordings during in-person sessions, including eye-tracking, heart rate monitoring, and muscle activity measurement.
- Perform short online versions of the cognitive tasks between visits.
- Healthy control participants will complete the same procedures, except for antidepressant treatment exposure, while the depressed group will be followed over time before and after treatment.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Romain Ligneul, PhD
- 電話番号:+33 04 72 13 89 00
- メール:romain.ligneul@inserm.fr
研究連絡先のバックアップ
- 名前:Méline Devaluez, PhD
- 電話番号:+33 04 37 91 55 14
研究場所
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-
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Bron、フランス、69500
- Centre de Recherche en Neuroscience de Lyon
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コンタクト:
- Romain Ligneul, PhD
- 電話番号:+33 04 72 13 89 00
- メール:romain.ligneul@inserm.fr
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria - applicable to all participants:
- Affiliated with a social security or national health insurance system, or entitled to such coverage.
- Male or female, aged 18 to 55 years.
- Fluent in spoken and written French.
- Normal or corrected-to-normal vision.
- Access to a computer and an internet connection.
- Available for the 8-week study period following treatment initiation (patients) or the baseline visit (healthy controls).
- Willing to use an effective method of contraception (condom, oral contraceptive pill, abstinence, or intrauterine device).
Additional inclusion criteria for the depressed patient group:
- Eligible for antidepressant monotherapy with a selective serotonin reuptake inhibitor (SSRI: sertraline, fluoxetine, citalopram, or paroxetine) or a serotonin-norepinephrine reuptake inhibitor (SNRI: venlafaxine or duloxetine), with or without concomitant treatment with a short half-life benzodiazepine (<12 hours; e.g., oxazepam, lorazepam, or clotiazepam), for which the prescription has been issued but treatment has not yet been initiated.
- Montgomery-Åsberg Depression Rating Scale (MADRS) score >6 and <35 (corresponding to mild-to-moderate depression), assessed during the routine clinical visit with the treating physician.
- No evidence of suicidal ideation, high-risk behaviors, history of suicide attempt, or overt psychotic symptoms that could compromise participant safety.
- No severe medical condition or unstable physiological state considered incompatible with study participation by the referring physician, including but not limited to unstable chronic diseases (e.g., hypertension or diabetes), respiratory insufficiency, cardiovascular insufficiency, or renal insufficiency.
Exclusion criteria applicable to all participants:
- History of a major depressive episode within the past 3 years.
- Use of antidepressants, mood stabilizers, or antipsychotic medication within the past 3 years.
- Diagnosis of a neurological or psychiatric disorder affecting central nervous system function (including bipolar disorder, schizophrenia, or other psychotic disorders according to DSM-5 criteria).
- Pregnancy or breastfeeding (self-reported).
- Individuals under legal protection (guardianship, curatorship, or judicial protection measures).
- Current participation in another interventional clinical trial or ongoing exclusion period following a previous clinical trial.
- Planned initiation during the study of a medication or substance known to interfere with serotonergic activity (including MDMA, LSD, psilocybin, ketamine, cocaine, 5-HT2A receptor antagonist antipsychotics, triptans, or lithium).
- Use of serotonin-acting recreational drugs within the previous 6 months (including cocaine, MDMA, or psychedelic substances).
- Refusal to be informed of the potential discovery of a clinically significant incidental finding.
Additional exclusion criteria for the depressed patient group
- Antidepressant treatment already initiated before study enrollment.
- Use of benzodiazepines within the 12 hours preceding an experimental session.
- Treatment with benzodiazepines other than oxazepam, lorazepam, or clotiazepam.
- Current hospitalization.
- Risk of suicidal behavior, defined as a score of ≥2 on the "zest for life" ("élan de vie") item of the Montgomery-Åsberg Depression Rating Scale (MADRS).
- Current treatment considered clinically incompatible with study participation by the physician responsible for recruitment.
Additional exclusion criteria for the healthy volunteer group :
Current or previous diagnosis of a depressive or anxiety disorder.
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
- 主な目的:基礎科学
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Depression group
Patients presenting a depressive episode and receiving serotonergic antidepressant treatment
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Participants are prescribed serotonergic antidepressants such as fluoxetine, sertraline, escitalopram, paroxetine, or serotonin-norepinephrine reuptake inhibitor (SNRI).
Dosage, formulation, frequency, and treatment duration are determined by the treating clinician.
No experimental manipulation of medication is performed within the study.
The intervention is characterized to assess its association with cognitive performance, reaction time (RT), accuracy, and controllability-related decision-making.
Experimental tasks assessing cognition, decision-making, and perceived controllability.
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実験的:Control group
Healthy participants who are not receiving serotonergic antidepressant treatment.
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Experimental tasks assessing cognition, decision-making, and perceived controllability.
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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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Controllability Estimation Bias in depressed patients
時間枠:Change between baseline and week 8
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normalization of the controllability estimation bias in patients with depression after 8 weeks of treatment with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI).
The assessment of controllability is not obtained directly from the participant, but through a computational model inferred from their behavioural data (reaction time (RT), prediction accuracy (percentage of correct responses) and error rate)
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Change between baseline and week 8
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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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Controllability Estimation Bias in Depressed Patients vs Healthy Controls
時間枠:Baseline
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This measure compares the controllability estimation bias between participants with a current depressive episode and healthy controls using a behavioral task assessing perceived control over environmental outcomes
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Baseline
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Romain Ligneul, PhD、Institut National de la Santé Et de la Recherche Médicale, France
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
- 2026-A00663-48
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