Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
Randomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
調査の概要
詳細な説明
Depression is a common, but treatable, comorbid condition often seen in persons with Idiopathic Parkinson Disease (iPD). Depression in Parkinson Disease may be hard to treat as patients with iPD may be sensitive to side effect of medication. As a result, other treatments which have better side effects profiles than antidepressants may be equivalent (or better) options.
OnabotulinumtoxinA is a purified formulation of botulinum toxin serotype A which is widely utilized for neurological (and cosmetic) purposes in medicine. OnabotulinumtoxinA has preliminary studies showing it may be beneficial for the treatment of Major Depressive Disorder when given in isolated injections to facial muscles (corrugator and procerus). When given in low doses, onabotulinumtoxinA is thought to have minimal side effects.
The investigators propose that a single treatment onabotulinumtoxinA may improve symptoms of depression in persons with Parkinson Disease over three months compared to placebo. The investigators plan to use both subjective and objective evaluations of depression symptoms and regular physical exams to ensure physical (motor) symptoms of Parkinson Disease do not worsen.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21287
- Johns Hopkins University School Of Medicine
-
-
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
Inclusion Criteria:
- Written informed consent is obtained in the English language;
- They are a 18 to 95 years old;
- They meet United Kingdom Brain Bank Criteria for probable idiopathic Parkinson disease;
- They meet Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive disorder (MDD) as diagnosed by the M.I.N.I. at screening;
- They are judged by the investigator to have the capacity to understand the nature of the study;
- They are willing to comply with all the requirements of the study;
- They are considered by the investigator to be likely to adhere to the protocol.
Exclusion Criteria:
- They have been treated with onabotulinumtoxinA injected into the facial muscles for any reason in the 3 months prior to screening;
- They have Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
- They endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening;
- They have a history of substance abuse or dependence in the 2 months prior to screening;
- They test positive for illicit drugs on urine screen, and this has not been adequately explained to the satisfaction of the investigator
- They are considered to be at significant risk of committing homicide;
- They have an unstable medical condition;
- Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study;
- There has been a change in their PD medication or psychotherapy treatment regimen in the 30 days preceding screening;
- They are regarded, for any reason, by the principal investigator as being an unsuitable candidate for the protocol.
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 |
|---|---|
|
実験的：Intervention
One injection of onabotulinumtoxinA (29 units for women and 40 units for men) will be injected into two facial muscles - the corrugator and procerus.
|
OnabotulinumtoxinA (29 units for women; 40 units for men) diluted with 0.9% sodium chloride (saline) solution to 40 units per milliliter (mL) (0.725 mL for women, 1 mL for men)
他の名前：
|
|
プラセボコンパレーター：Control
One injection of saline solution will be injected into two facial muscles - the corrugator and procerus.
|
0.9% sodium chloride solution (saline) solution injections (0.725mL for women, 1mL for men)
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 |
|---|---|---|
|
Hamilton Rating Scale for Depression (HDRS)
時間枠：Baseline and two visits over three months (weeks 6 and 12)
|
Improvement on a clinician-rated objective scale for depression as assessed over two weeks (6 weeks and 12 weeks after treatment)
|
Baseline and two visits over three months (weeks 6 and 12)
|
|
Clinical Global Impression - Improvement (CGI-I)
時間枠：Baseline and two visits over three months (weeks 6 and 12)
|
Improvement on a measure of global change from screening to study discontinuation
|
Baseline and two visits over three months (weeks 6 and 12)
|
|
Clinical Global Impression - Severity (CGI-S)
時間枠：Baseline and two visits over three months (weeks 6 and 12)
|
Improvement on measure of global illness severity from screening to study discontinuation
|
Baseline and two visits over three months (weeks 6 and 12)
|
|
Beck Depression Inventory II
時間枠：Baseline and two visits over three months (weeks 6 and 12)
|
Improvement on a participant-rated subjective scale for depression as assessed over two visits
|
Baseline and two visits over three months (weeks 6 and 12)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Severity Score for Glabellar Frown Lines
時間枠：Baseline and two visits over three months (weeks 6 and 12)
|
Assessment of change in participant frowning before and after onabotulinumtoxinA injections and relationship with depressive symptoms
|
Baseline and two visits over three months (weeks 6 and 12)
|
協力者と研究者
スポンサー
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00082708
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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。
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。