Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
An Open-Label, Flexible-Dose Trial of the Safety and Efficacy of Geodon in Non-Rapid-Cycling Bipolar II Patients With Major Depression
調査の概要
詳細な説明
Bipolar II disorder is largely unstudied, with much less known about its treatment in comparison to Bipolar I disorder. While established mood stabilizers treat and prevent subsequent episodes of hypomania, chronic or recurrent depressions are harder to treat or prevent. In general the treatment of depression in Bipolar II patients is often complicated and there is no clinical unanimity on what approaches to follow. Administration of proven antidepressants would seem most appropriate and are most often used, but their use often involves a number of difficulties. Among these are:
- antidepressant efficacy is established for unipolar patients and extrapolation to Bipolar II patients is done without empirical support
- Bipolar II patients can have switches into hypomanic behavior in response to antidepressant treatment given as monotherapy
- even when mood stabilizers are concomitantly given, switches to hypomanic states still occur when antidepressants are added
- antidepressants can cause cycle acceleration or induce rapid cycling when given to Bipolar II patients
- non-response and loss of response are common reactions to antidepressants in Bipolar II patients
This study will also assess the tolerability of Geodon in the treatment of patients diagnosed with Bipolar II disorder who currently meet criteria for a Major Depressive Episode by examining the incidence of adverse events and the withdrawal rate due to adverse events.
This will be an open-label study. Subjects will be treated for 8 weeks with Geodon, starting at a dose of 20 mg twice per day. The maximum dose will be 60 mg twice per day. Subjects will have a physical exam, electrocardiogram (ECG), standard laboratory tests and a urine drug screen at the screen visit.
Efficacy evaluations will include 17-item Hamilton Depression Scale, Hamilton Anxiety Scale (HAM-D), Montgomery-Asberg Depression Rating Scale, and the Young Mania Rating Scale. Social outcome will be measured with a quality-of-life scale (the Q-LES-Q). Overall efficacy will be rated using the Clinical Global Severity and Improvement Scales.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
New York
-
New York、New York、アメリカ、10024
- Medical Research Network, L.L.C.
-
-
Texas
-
Plano、Texas、アメリカ、75024
- The Mech Center
-
-
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:
- patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania
- patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration
- minimum score of 18 on the 17-item HAM-D at screen and baseline
Exclusion Criteria:
- patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia
- patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture
- Suicidal ideation or history that makes participation in a clinical trial unduly risky
- unstable medical conditions or any abnormality in thyroid function
- patients with a QTc of 450msec or greater on the initial ECG
- patients requiring concomitant psychotropic drugs will not be eligible, although patients on such drugs who can undergo washout will be eligible. such patients must have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4 weeks for fluoxetine and depot neuroleptics
- the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from insomnia, but cannot be taken the night before a scheduled assessment
- patients with dementia or substance abuse in the last 6 months
- pregnant or lactating women will be excluded, as will those not using adequate forms of contraception
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Ziprasidone
Ziprasidone monotherapy, 20-60 mg BID.
|
Ziprasidone 20-60 mg BID, taken orally.
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 |
|---|---|---|
|
The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores
時間枠：Week 8
|
Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.
|
Week 8
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)
時間枠：Week 8
|
Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety.
|
Week 8
|
|
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale
時間枠：Week 8
|
Montgomery-Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression.
|
Week 8
|
|
Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2
時間枠：Week 8
|
Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. 18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial. |
Week 8
|
|
Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint
時間枠：Week 8
|
Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.
|
Week 8
|
|
Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
時間枠：Week 8
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction.
|
Week 8
|
|
Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)
時間枠：Week 8
|
Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression.
|
Week 8
|
協力者と研究者
捜査官
- 主任研究者：Michael R Liebowitz, MD、Medical Research Network, L.L.C.
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。