EUCTR2009-016648-38-FI进行中（未招募）不适用
A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 370
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are included in the study if all of the following criteria are met (NOTE: All psychiatric diagnoses are made on the basis of DSM-IV-TR criteria.):
- •(a) The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder.
- •(b) Inclusion criterion (b) was replaced by (b1).
- •(b1) The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression.
- •Inclusion criterion (c) was replaced by (c1), (c1) was replaced by (c2), and (c2) was replaced by (c3).
- •(c3) During the previous double-blind study, the patient must have been taking 1 (or 2) of the
- •following protocol-allowed mood stabilizers:
- •valproic acid
- •olanzapine
- •quetiapine
- •aripiprazole
- •lamotrigine
- •risperidone
- •ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine)
- •The following criteria must also be met:
- •The mood stabilizers must be taken in an oral formulation, with the exception of risperidone,
- •which can be either in an oral or long-acting injection formulation.
- •The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium,
- •valproic acid, or lamotrigine.
- •The patient must be judged by the investigator to be compliant with treatment with the mood
- •stabilizer(s).
- •The patient must be willing to continue treatment with the same protocol-allowed mood
- •stabilizer(s) at dosages considered appropriate by the investigator.
- •Minimum dosage requirements, if applicable, and the lengths of time they are required are
- •provided in the protocol.
- •(d) The patient has a YMRS total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment.
- •(e) Written informed consent is obtained.
- •(f) The patient is a man or woman 18 through 65 years of age at the time of enrollment in the double-blind study.
- •(g) The patient is in good health (except for diagnosis of bipolar I disorder) as judged by the investigator, on the basis of medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, and urinalysis results.
- •(h) Inclusion criterion (h) was replaced by (h1).
- •(h1) Women of childbearing potential (women who have not reached menopause, women who are less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), and
- •steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
- •(i) The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
- •(j) The patient has permanent accommodations and means of being contacted by the study center.
- •(k) The patient agrees not to enroll in any other clinical study while participating in this study.
- •(l) The patient may temporarily reside in a clinic or hospital, or may currently be treated in an over-night medical facility at the beginning of and throughout the study, in a manner cons
排除标准
- •Patients are excluded from participating in this study if 1 or more of the following criteria are met (NOTE: All psychiatric diagnoses are made on the basis of DSM-IV-TR criteria.):
- •(a) The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study.
- •(b) The patient has psychotic symptoms or had psychosis during the double-blind study.
- •(c) The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present; or at enrollment has a score of 2 or more for item 18 on the IDS-C30.
- •(d) The patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study.
- •(e) The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.
- •Exclusion criterion (f) was replaced by (f1).
- •(f1) The patient has a history of any clinically significant cutaneous drug reaction, or a history of
- •clinically significant hypersensitivity reaction, including multiple allergies.
- •(g) The patient has a past or present seizure disorder (except history of a single febrile seizure), or a history of clinically significant head trauma (eg, brain damage) or of brain surgery.
- •(h) The patient has left ventricular hypertrophy or the patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome.
- •(i) The patient has human immunodeficiency virus (HIV).
- •(j) The patient has any clinically significant uncontrolled medical condition, treated or untreated.
- •(k) In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination.
- •(l) The patient has evidence of current non-medical substance use on urine drug screen (UDS) or by history.
- •(m) The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
- •(n) The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (ADME) (including gastrointestinal surgery).
- •(o) The patient is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor.
- •(p) Exclusion criterion (p) is replaced by (p1).
- •(p1) The patient is an inpatient without consent or is institutionalized for reasons other than the conditions stipulated in inclusion criterion a. (NOTE: Also refer to inclusion criterion (l).)
研究者
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