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

Conditions: Major Depression Associated With Bipolar I Disorder
MedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depression

Registration Number: EUCTR2007-007555-14-BG

Lead Sponsor: Cephalon, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

(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
episode.
(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
the study.
(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

Exclusion Criteria

(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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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