The purpose of this study is to look at the safety, effectiveness, and tolerability of armodafinil when used for 6 months with mood stabilizers in subjects with major depression associated with bipolar I disorder.

• Conditions: Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; MedDRA version: 14.1Level: LLTClassification code 10004911Term: Bipolar affective disorder, depressedSystem Organ Class: 10037175 - Psychiatric disorders; Major Depression Associated With Bipolar I Disorder.

• Registration Number: EUCTR2009-016648-38-IT
• Lead Sponsor: CEPHALON FRANCE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Patients are included in the study if all the following criteria are met: (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)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. (C)During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; aripiprazole; olanzapine; ziprasidone taken in combination with lithium or valproic acid; lamotrigine; or risperidone. (d) The patient has a YMRS totals 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) The patientis a man or woman 18 through 65 years of age at the time of enrollment in the double-blind study. (f)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.(g)Women of childbearing potential 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.(h)The patient is willing and able to comply with restrictions and to attend regularly scheduled clinic visits as specified in this protocol.(i)The patient has permanent accommodations and means of being contacted by the study center.(j)The patient agrees not to enroll in any other clinical study while participating in this study.(k)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 throught the study, in a manner consistent with medical practices as related to the treatment of depression associated with bipolar I disorder.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 370
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients are excluded from particiapting in this study if 1 or more of the following criteria are met.(a)The patient has any Axis I or Axix 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 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.(f)The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or a history of multiple clinically relevant 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 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 immunodeficieny 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 withdrawan 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)The patient is an inpatient without consent or is institutionalized for reasons other than the conditions stipulated in inclusion criterion a.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified