EUCTR2007-007555-14-BG进行中（未招募）不适用
An 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study toEvaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as AdjunctiveTherapy in Adults With Major Depression Associated WithBipolar I Disorder
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •(a) The patient has a diagnosis of Bipolar I Disorder according to the DSM-IV-TR
- •criteria as determined by the SCID and is currently experiencing a major depressive
- •(b) The investigator has established, by medical record documentation or by history
- •from the patient and reliable informants, that the patient has had at least 1 previous
- •manic or mixed episode, which resulted in functional impairment and was treated (or
- •should have been treated) with a mood stabilizer or antipsychotic medication.
- •(c) The patient has had no more than 6 mood episodes in the last year.
- •(d) The patient’s current major depressive episode must have started no less than
- •4 weeks and no more than 12 months prior to the screening visit.
- •(e) NOTE: The following inclusion criterion is no longer effective with the
- •implementation of amendment 2, it is replaced by inclusion criterion (o)
- •(f) The patient has been on a stable dosage of all other permitted medications (with the
- •exception of medication to be used on an as-needed basis) for 4 weeks prior to the
- •baseline visit
- •(g) The patient has a QIDS-SR 16 score that is greater than or equal to 13 at the
- •screening and baseline visits.
- •(h) The patient has a CGI-BP rating (for depression) of 4 (moderately ill) or higher at the
- •screening and baseline visits.
- •(i) The patient has a YMRS total score of 10 or less and a score of 0 or 1 on items 1
- •through 3 at the screening and baseline visits.
- •(j) Written informed consent is obtained.
- •(k) The patient is a man or woman 18 through 65 years of age.
- •(l) The patient is in good health (except for diagnosis of Bipolar I Disorder) as judged
- •by the investigator.
- •(m) Women of childbearing potential (not surgically sterile or 2 years postmenopausal),
- •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
- •(n) The patient must be willing and able to comply with study restrictions.
- •(o) The patient is currently being treated with 1 or 2 of the following
- •drugs: lithium, olanzapine, or valproic acid and has been taking the drug for at least
- •8 weeks before screening. The patient has been on a therapeutic dose (for
- •olanzapine), or maintained at a therapeutic blood level (for lithium or valproic acid),
- •of these medications for at least 4 weeks prior to the baseline visit. The patient is
- •prepared to remain at this dosage for the duration of the study (unless dosage
- •adjustments are required to maintain therapeutic levels).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(a) NOTE: The following exclusion criterion is replaced by exclusion criterion (cc):
- •(b) The patient has active psychotic symptoms.
- •(c) The patient has a history of an attention-deficit/hyperactivity disorder, eating
- •disorder, and/or obsessive compulsive disorder (OCD).
- •(d) NOTE: The following exclusion criterion is replaced by exclusion criterion (dd):
- •(e) NOTE: The following exclusion criterion is replaced by exclusion criterion (ee):
- •(f) The patient has a history of stimulant-induced mania.
- •(g) In the judgment of the investigator, the patient is at risk of imminent self-harm.
- •(h) The patient has a history of homicidal ideation or significant aggression.
- •(i) The patient has a history of any clinically significant cutaneous drug reaction.
- •(j) The patient has a past or present seizure disorder, head trauma clinically significant or past neurosurgery.
- •(k) The patient has any clinically significant uncontrolled medical or surgical condition
- •(l) The patient has HIV.
- •(m) The patient has any clinically significant deviation from normal in the physical examination.
- •(n) The patient has a clinical laboratory test value(s) outside the range(s) specified.
- •(o) NOTE: The following exclusion criterion is replaced by exclusion criterion (dd):
- •(p) The patient has previously received modafinil or armodafinil, or the patient has a
- •known sensitivity to any ingredients in the study drug tablets.
- •(q) The patient has used any investigational product within 30 days of screening.
- •(r) The patient is using any exclusionary medication.
- •(s) Psychotherapeutic intervention has been initiated within 2 months before the
- •screening visit or between the screening and baseline visits.
- •(t) The patient has received cognitive behavior therapy (CBT).
- •(u) The patient has received electroconvulsive therapy (ECT).
- •(v) The patient has a decrease of 25% or more in the MADRS score.
- •(w) The patient has a decrease of 30% or more in the QIDS-SR 16 score.
- •(x) The patient has been sleeping an average of less than 6 hours per night.
- •(y) The patient is unlikely to comply with the study protocol
- •(z) The patient is a pregnant or lactating woman.
- •(aa) The patient has any disorder that may interfere with drug absorption, distribution,
- •metabolism, or excretion (including gastrointestinal surgery).
- •(bb) The patient has a HAM-A score of 20 or more at the baseline visit.
- •(cc) The patient has any Axis I disorder, according to DSM-IV-TR, apart from Bipolar I Disorder.
- •(dd) The patient has a history of alcohol or substance dependence or abuse (with the exception of nicotine), according to DSM-IV-TR,
- •(ee) The patient has any Axis II disorder, according to DSM-IV-TR.
- •(ff) The patient has a positive UDS for anything other than cannabis. Patients with a positive result for cannabis may be enrolled at the discretion of the medical monitor.
- •(gg) The patient has no permanent accommodations and no means of
- •being contacted by the study center.
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