Major Depression Associated With Bipolar I Disorder MedDRA version: 9.1 Level: LLT Classification code 10057840 Term: Major depression
Conditions
Interventions
Trade Name: Nuvigil
Product Name: Armodafinil
Product Code: CEP-10953
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: armodafinil
CAS Number: 112111-43-0
Current Sponsor code: CEP-10953
O
R-modafinil, levo modafinil, l-modafinil, (-)-modafinil, (-)-modafinil isomer
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo
Sponsors
Cephalon, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode. This will be assessed by the change from baseline to endpoint in the total score from the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30).;Secondary Objective: to evaluate the effectiveness of armodafinil treatment as assessed by the mean change from baseline, in the total score from MADRS, from the IDS-C30 and from the QIDS-SR 16 • the effectiveness of armodafinil in reducing functional disability as assessed from Q-LES-Q-SF • the effect of armodafinil on symptoms of anxiety as assesed from HAM-A • the proportion of responders according to CGI-BP ratings • the proportion of responders as assessed by the IDS-C30 • the proportion of patients in remission as assessed by the IDS-C30 • the proportion of patients achieving sustained remission and response as assessed from the IDS-C30 • the effect of armodafinil on sleep as assessed on the IDS-C30 • the effect of armodafinil on depressed mood as assessed by the MADRS and IDS-C30 • key features of depressive retardation as assessed in IDS-C30 • the safety and tolerability of armodafinil • the impact of armodafinil on the pharmacokinetics of olanzapine and/or valproic acid ;Primary end point(s): The primary efficacy measure for this study is the IDS-C30 assessed at week 8 or early termination. | — |
Countries
Bulgaria, Hungary
Outcome results
None listed