MDD患者におけるGM-2505の安全性と忍容性を評価する第2a相試験
大うつ病性障害患者を対象に、GM-2505を2週間間隔で2回反復投与した場合の安全性と忍容性を評価する第2a相試験。
This is a three-part Phase 2a study. The aim of Part A is to assess the safety and tolerability and preliminary antidepressant efficacy in patients with MDD who are not currently on an antidepressant therapy. The aim of Part B is to assess the antidepressant efficacy, safety and tolerability in patients with MDD who are partial responders while on a current and adequate single SSRI or SNRI treatment. Part C aims to replicate the monotherapy findings of Part A, but with a lower control group dose.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Manchester、イギリス
- MAC Clinical Research
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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
説明
Key Inclusion Criteria:
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Patients are male or female, of any ethnic origin.
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Patients are aged between 18 to 65 years, inclusive.
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Patients meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for recurrent MDD without psychotic features, as assessed with the Mini-International Neuropsychiatric Interview (MINI) at Screening.
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Current moderate to severe MDD diagnosis confirmed with a MADRS-SIGMA
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Concomitant depression therapy:
- (Part A) Patients need to be stable and must not have taken any SSRI or SNRI for at least 6 weeks prior to Screening and must be willing to avoid starting a new pharmacological treatment for MDD until the end of the study procedures and assessments. Discontinuing current treatment is not allowed if done for the purposes of achieving eligibility for this study.
- (Part B) Patients need to be on stable treatment with any SSRI or SNRI for at least 6 weeks prior to screening and must be willing to remain on the SSRI or SNRI for the duration of the trial
- Patients receiving any form of psychotherapy or counselling must have been receiving therapy at Screening and must be willing to remain in therapy until the end of the study procedures and assessments.
Key Exclusion Criteria:
- Patient has current or past primary DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar, or related disorders. A current diagnosis of PTSD, complex PTSD and borderline personality disorder are exclusionary. Other psychiatric disorders besides MDD should not be the primary disorder.
- In first degree relatives, a history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder or schizoaffective disorder.
- Current or prior (six weeks before Screening) use of any SSRI/SNRI medication (Part A only).
- Current or prior (five weeks before Screening) use of any monoamine oxidase inhibitor ([MAO-I]; including phenelzine, tranylcypromine, isocarboxazid, iproniazid, selegiline, rasagiline, the reversible MAO-I moclobemide and the antibiotic linezolid).or any tricyclic antidepressant
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
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：GM-2505 の低用量から高用量まで
|
IV |
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実験的：中用量から高用量の GM-2505
|
IV |
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アクティブコンパレータ：GM-2505の実験的な極低用量から極低用量
|
IV |
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 |
|---|---|---|
|
Safety and Tolerability (Part A, B, and C)
時間枠：99 Days
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The primary objective of this study is to evaluate the safety and tolerability of two doses of GM-2505 administered to MDD patients at a 2-week interval between doses. |
99 Days
|
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MADRS Score (Part B and C)
時間枠：29 Days
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The estimated difference between Arm 1 and Arm 2 in the changes from baseline in MADRS-SIGMA total score |
29 Days
|
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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MADRS-SIGMA total score (Part A)
時間枠：Days 14 and 29
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Change in MADRS-SIGMA total score between Baseline and Day 29 and comparison of Day 1 low dose vs moderate dose at Day 14 |
Days 14 and 29
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MADRS-SIGMA total score (Part B and C)
時間枠：All additional timepoints
|
MADRS-SIGMA scores (change from baseline) |
All additional timepoints
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MADRS-SIGMA total score (Part B and C)
時間枠：Days 14, 29, 43, 71, and 99
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Response and Remission |
Days 14, 29, 43, 71, and 99
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PK of GM-2505 (Part C)
時間枠：Day 16
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Assess the pharmacokinetics of GM-2505 at very low, moderate, and high doses |
Day 16
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Gerard Marek, MD、Gilgamesh Pharmaceuticals
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 (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
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