A Study of Flexible or Fixed Dose LY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment
2018年3月25日 更新者：Eli Lilly and Company
A Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 12 mg to 18 mg Once Daily and LY2216684 Fixed-Dose 6 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment
The purpose of this study is to assess if LY2216684 (flexible dose of 12 to 18 milligrams [mg] or fixed dose of 6 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with Major Depressive Disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.
調査の概要
詳細な説明
Following the Confirmation (CF) Phase, participants were randomized to adjunctive LY2216684 or adjunctive placebo if they had <25% improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over the past 3 weeks and a current MADRS total score ≥14.
Participants who did not meet criteria received adjunctive placebo to preserve the blind.
研究の種類
介入
入学 (実際)
1480
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35216
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Arizona
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Phoenix、Arizona、アメリカ、85032
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California
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Chino、California、アメリカ、91710
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Glendale、California、アメリカ、91204
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Imperial、California、アメリカ、92251
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National City、California、アメリカ、91950
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Sherman Oaks、California、アメリカ、91403
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Colorado
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Colorado Springs、Colorado、アメリカ、80907
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Florida
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Clearwater、Florida、アメリカ、33761
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Coral Gables、Florida、アメリカ、33145
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Fort Lauderdale、Florida、アメリカ、33319
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Tampa、Florida、アメリカ、33613
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Georgia
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Atlanta、Georgia、アメリカ、30308
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Illinois
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Hoffman Estates、Illinois、アメリカ、60169
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Indiana
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Indianapolis、Indiana、アメリカ、46260
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Kansas
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Prairie Village、Kansas、アメリカ、66206
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Wichita、Kansas、アメリカ、67205
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Maryland
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Baltimore、Maryland、アメリカ、21285
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Massachusetts
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Haverhill、Massachusetts、アメリカ、01830
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Weymouth、Massachusetts、アメリカ、02190
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Mississippi
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Flowood、Mississippi、アメリカ、39232
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Missouri
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O'Fallon、Missouri、アメリカ、63368
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New York
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Brooklyn、New York、アメリカ、11235
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New York、New York、アメリカ、10021
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Ohio
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Beachwood、Ohio、アメリカ、44122
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73103
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
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Texas
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Houston、Texas、アメリカ、77096
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Rab、クロアチア、51280
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Zagreb、クロアチア、10090
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Bratislava、スロバキア、85101
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Kosice、スロバキア、04001
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Michalovce、スロバキア、SK-071 01
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Rimavska Sobota、スロバキア、97901
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Roznava、スロバキア、04801
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Horovice、チェコ、268 31
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Hostivice、チェコ、25201
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Kladno、チェコ、27201
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Olomouc、チェコ、77900
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Prague、チェコ、100 00
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Strakonice、チェコ、38601
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Usti Nad Labem、チェコ、400001
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Helsinki、フィンランド、00100
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Joensuu、フィンランド、80100
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Kuopio、フィンランド、70110
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Tampere、フィンランド、33200
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Turku、フィンランド、20100
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San Juan、プエルトリコ、00918
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Chiba、日本、270-0014
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Fukuoka、日本、810-0035
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Fukushima、日本、961-0021
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Hyogo、日本、661-0002
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Kanagawa、日本、247-0056
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Tokyo、日本、100-0006
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Clinical diagnosis of Major Depressive Disorder (MDD)
- Using a reliable method of birth control
- Are taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment within the participant's country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country
- Have a partial response to SSRI treatment
- Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment
- Reliable and able to keep all scheduled appointments
Exclusion Criteria:
Presence of another primary psychiatric illness:
- Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition other than major depression within 1 year of screening
- Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias)
- Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder
- Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine
- Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol
- Have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, and history of urinary hesitation or retention
- Use of excluded concomitant or psychotropic medication other than SSRI
- Have initiated or discontinued hormone therapy within the previous 3 months of prior to enrollment
- History of treatment-resistant depression as shown by lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the participant has treatment-resistant depression
- Have a lifetime history of vagal nerve stimulation (VNS) transcranial magnetic stimulation (TMS), or psychosurgery
- Have received electroconvulsive therapy (ECT) in the past year
- Enrollment in a clinical study for an investigational drug
- Serious or unstable medical condition
- History of seizure disorders
- Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or any time during the study
- Participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：12 or 18 mg flexible dose LY2216684 + SSRI
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) Prior to entering the Adjunctive Treatment (AT) Phase, participants completed a 3-week Confirmation (CF) Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to a 12 or 18 mg flexible dose of LY2216684. During the AT Phase, participants first received 6 mg LY2216684 QD for 3 days, followed by 12 mg QD for the next 11 days. Then, based on efficacy and tolerability, dosage could be increased to 18 mg QD over the next 6 weeks. Participants on 18 mg QD could have had their dose decreased back to 12 mg QD. Participants who completed the AT Phase or discontinued early had the option to enter the Discontinuation (DC) Phase. During the 1-week abrupt DC Phase, participants maintained their SSRI treatment. |
他の名前：
参加者は、少なくとも6週間前にSSRIを服用している必要があり、研究を通じて安定した用量を継続する必要がありました
他の名前：
|
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実験的：6 mg fixed dose LY2216684 + SSRI
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI Prior to entering the AT Phase, participants completed a 3-week CF Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to 6 mg fixed dose of LY2216684. During the AT Phase, participants received a 6 mg fixed dose of LY2216684 adjunctive to their SSRI for 8 weeks. Participants who completed the AT Phase or discontinued early had the option to enter the DC Phase. During the 1-week abrupt DC Phase, participants maintained their SSRI treatment. |
他の名前：
参加者は、少なくとも6週間前にSSRIを服用している必要があり、研究を通じて安定した用量を継続する必要がありました
他の名前：
|
|
プラセボコンパレーター：Placebo + SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI Prior to entering the AT Phase, participants completed a 3-week CF Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to placebo. During the AT Phase, participants received placebo (administered orally, QD) adjunctive to their SSRI for 8 weeks. Participants who completed the AT Phase or discontinued early had the option to enter the DC Phase. During the 1-week abrupt DC Phase, participants maintained their SSRI treatment. |
参加者は、少なくとも6週間前にSSRIを服用している必要があり、研究を通じて安定した用量を継続する必要がありました
他の名前：
|
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 |
|---|---|---|
|
Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
時間枠：Randomization, 8 weeks
|
The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts).
Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
|
Randomization, 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
EuroQol Questionnaire-5 Dimension (EQ-5D) で無作為化から 8 週目に変更
時間枠：無作為化、8週間
|
EQ-5D ビジュアル アナログ スケールは、一般的な多次元の健康関連の生活の質を測定する機器です。
全体的な健康状態のスコアは、0 から 100 までのスケールでマークされたビジュアル アナログ スケールを使用して自己報告されます。0 は想像できる最悪の健康状態を表し、100 は想像できる最高の健康状態を表します。
最小二乗法 (LS) 平均は、混合モデル反復測定 (MMRM) を使用して、治療、治験責任医師、訪問、ベースライン スコア、訪問ごとの治療、および訪問ごとのベースライン スコアを調整して計算されました。
|
無作為化、8週間
|
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無作為化から8週目への血圧の変更
時間枠：無作為化、8週間
|
血圧測定は、参加者が座った状態で収集されました。
各来院時に約 1 分間隔で収集された座位血圧の 3 つの測定値を平均し、来院の値として使用しました。
最小二乗法 (LS) 平均は、混合モデル反復測定 (MMRM) を使用して、治療、治験責任医師、訪問、ベースライン値、訪問ごとの治療、および訪問ごとのベースライン値を調整して計算されました。
|
無作為化、8週間
|
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無作為化から 8 週目に脈拍数を変更
時間枠：無作為化、8週間
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参加者が座位にいるときに脈拍測定値が収集されました。
最小二乗法 (LS) 平均は、混合モデル反復測定 (MMRM) を使用して、治療、治験責任医師、訪問、ベースライン値、訪問ごとの治療、および訪問ごとのベースライン値を調整して計算されました。
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無作為化、8週間
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モンゴメリー・アスバーグうつ病評価スケール (MADRS) の個別項目におけるランダム化から第 8 週への変更
時間枠：ランダム化、8週間
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MADRS は、抑うつ気分の症状の重症度を評価するスケールです。
MADRSには10項目のチェックリスト（悲しみ[明らかな]、悲しみ[報告されている]、内面の緊張、睡眠の減少、食欲の低下、集中力の低下、倦怠感、感じることができない、悲観的思考、自殺願望）があった。
項目は 0 ～ 6 のスケールで評価され、合計スコア範囲は 0 (抑うつ症状の重症度が低い) ～ 60 (抑うつ症状の重症度が高い) でした。
最小二乗法（LS）平均は、治療、治験責任医師、訪問、ベースライン項目スコア、訪問ごとの治療および訪問ごとのベースライン項目スコアを調整する混合モデル反復測定（MMRM）を使用して計算されました。
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ランダム化、8週間
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Change From Randomization to Week 8 in the Sheehan Disability Scale (SDS) Global Functional Impairment Score
時間枠：Randomization, 8 weeks
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The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3).
Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption.
The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score).
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in the Fatigue Associated With Depression (FAsD) Impact Subscale Score
時間枠：Randomization, 8 weeks
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The FAsD is a participant-rated scale with a total of 13 items.
Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always).
Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much).
The impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only).
Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school.
The FAsD impact subscale score ranges from 1 to 5. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.
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Randomization, 8 weeks
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Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 up to Week 8
時間枠：Randomization up to 8 weeks
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A MADRS total score of less than or equal to 10 was defined as remission criteria.
The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts).
Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Percentage of participants was calculated by dividing the number of participants who meet criteria for remission by the total number of participants analyzed, multiplied by 100%.
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Randomization up to 8 weeks
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Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement
時間枠：Randomization up to 8 weeks
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A MADRS total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement was defined as remission criteria at last 2 consecutive visits.
The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts).
Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.
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Randomization up to 8 weeks
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Change From Randomization to Week 8 in the Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score
時間枠：Randomization, 8 weeks
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The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression.
Each item was rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety and depression subscale.
Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8 to 10 represent 'borderline' and scores of 0 to 7 represent 'normal'.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.
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Randomization, 8 weeks
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Percentage of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization up to Week 8
時間枠：Randomization up to 8 weeks
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A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the MADRS total score was defined as response criteria.
The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts).
Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Percentage of participants was calculated by dividing the number of participants meeting response criteria at last visit by the total number of participants analyzed, multiplied by 100%.
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Randomization up to 8 weeks
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Change From Randomization to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
時間枠：Randomization, 8 weeks
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The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression.
Each item was rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety and depression subscale.
Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8 to 10 represent 'borderline' and scores of 0 to 7 represent 'normal'.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)
時間枠：Randomization, 8 weeks
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CGI-S measures severity of depression at the time of assessment compared with the start of treatment.
Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit
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Randomization, 8 weeks
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Change From Randomization to Week 8 in The Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score
時間枠：Randomization, 8 weeks
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The FAsD is a participant-rated scale with a total of 13 items.
Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always).
Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much).
The experience subscale score was derived by taking the mean of Items 1 through 6, and the average score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant).
Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
時間枠：Randomization, 8 weeks
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The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score).
Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
時間枠：Randomization, 8 weeks
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The Q-LES-Q-SF is a self-administered 16 item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point Likert scale (1=very poor and 5=very good).
The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70.
The raw scores are converted to and expressed as the percentage of the maximum possible score.
Higher scores indicate higher levels of enjoyment/satisfaction.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Percentage of Participants With Treatment-emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
時間枠：Randomization through 8 weeks
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The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Suicidal ideation was defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation.
Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present at baseline.
Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants analyzed, multiplied by 100%.
A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Event module.
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Randomization through 8 weeks
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Change From Randomization to Week 8 in the Arizona Sexual Experiences (ASEX) Scale
時間枠：Randomization, 8 weeks
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The ASEX scale was used to assess sexual functioning in both males and females.
The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) of the 5 items of the ASEX scale.
Total scores ranged from 5 to 30, with higher scores indicating greater sexual dysfunction.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
時間枠：Randomization, 8 weeks
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The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being.
It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity.
Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent).
Total scores ranged from 7 to 42.
Higher scores indicate greater disease severity.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Pharmacokinetics: Plasma Concentrations of LY2216684
時間枠：Pre-randomization, 1 week, 4 weeks, and 8 weeks
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A validated bioanalytical assay was used to determine plasma LY2216684 concentrations.
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Pre-randomization, 1 week, 4 weeks, and 8 weeks
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協力者と研究者
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一般刊行物
- Stauffer VL, Liu P, Goldberger C, Marangell LB, Nelson C, Gorwood P, Fava M. Is the Noradrenergic Symptom Cluster a Valid Construct in Adjunctive Treatment of Major Depressive Disorder? J Clin Psychiatry. 2017 Mar;78(3):317-323. doi: 10.4088/JCP.15m09972.
- Ball SG, Ferguson MB, Martinez JM, Pangallo BA, Nery ES, Dellva MA, Sparks J, Zhang Q, Liu P, Bangs M, Goldberger C. Efficacy outcomes from 3 clinical trials of edivoxetine as adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment. J Clin Psychiatry. 2016 May;77(5):635-42. doi: 10.4088/JCP.14m09619.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年3月1日
一次修了 (実際)
2013年8月1日
研究の完了 (実際)
2013年8月1日
試験登録日
最初に提出
2010年8月20日
QC基準を満たした最初の提出物
2010年8月23日
最初の投稿 (見積もり)
2010年8月24日
学習記録の更新
投稿された最後の更新 (実際)
2018年4月24日
QC基準を満たした最後の更新が送信されました
2018年3月25日
最終確認日
2018年3月1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
- 12182
- H9P-MC-LNBQ (その他の識別子：Eli Lilly and Company)
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。