Retrospective Observational Study DIANA Study (DIANA)
Retrospective Observational Study to Estimate the Duration of Initial Antidepressant Treatment in Patients With Recurrent Depressive Disorder Who Demonstrated a Suboptimal Response to Therapy: DIANA Study
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Ivanovo、ロシア連邦
- Research Site
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Kazan、ロシア連邦
- Research Site
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Moscow、ロシア連邦
- Research Site
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Nizhniy Novgorod、ロシア連邦
- Research Site
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Rostov-on-Don、ロシア連邦
- Research Site
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Saint-Petersburg、ロシア連邦
- Research Site
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Stavropol、ロシア連邦
- Research Site
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Yaroslavl、ロシア連邦
- Research Site
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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
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:
1. Female or male aged between 18 and 65 years Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013 3. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 weeks 4. Initial treatment changed because of a suboptimal response at physician's discretion, which is clearly documented in the patient's medical chart.
Exclusion Criteria:
Patients currently participating in any other clinical or non-interventional trial, or have completed their participation with the last 30 days.
2. Patients with current psychiatric or general medical conditions which require concomitant use of lithium, thyroid hormones, or atypical antipsychotics 3. Patients with unstable general medical condition. 4. Patients who were pregnant or were suspected to be pregnant during the period when a patient had received treatment for MDE (Major Depressive Episode).
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：回顧
コホートと介入
グループ/コホート |
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patients with major depression
Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013.
Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 week
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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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Duration of treatment considered as time between initiation of antidepressant monotherapy and the alteration and/or augmentation of pharmacotherapy
時間枠：up to 6 months
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Primary objective: The primary objective of this NIS is to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion.
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up to 6 months
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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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Pharmacotherapy strategy for the second line treatment
時間枠：up to 6 months
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Distribution of the various pharmacotherapy strategies following suboptimal response: (switch; augmentation; combination of switch and augmentation and discontinuation of pharmacotherapy) among the patients population.
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up to 6 months
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International Non-Proprietary Name (INN) of pharmacological agents prescribed for augmentation
時間枠：Up to 6 months
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Rate of the different pharmacological agents prescribed for augmentation; rout of their administration; mean and median duration of courses of treatment
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Up to 6 months
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Doses of pharmacological agents used for augmentation
時間枠：Up to 6 months
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Mean and median doses of pharmacological agents used for augmentation
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Up to 6 months
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Source of the patient's referral to a psychiatrist
時間枠：up to 6 months
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Distribution of various sources of the patient's referral to a psychiatrist (psychotherapist; neurologist; internist; physician of other speciality; psychologist; came himself; other; and not known
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up to 6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Alla Avedisova, Prof、Center of Social and Forensic Psychiatry, Moscow
- スタディディレクター：Karin Otter, PhD、AstraZeneca Russia
- 主任研究者：Anatoly Smulevich, Prof、Scientific centef of Mental Health, Moscow
- 主任研究者：Galina Mazo, Prof、St Petersburg Scientific Psyconeurology institute
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
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。