A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01072929
First received: February 19, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.


Condition Intervention Phase
Depression
Drug: Armodafinil 1
Drug: Armodafinil 2
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [ Time Frame: at all post-baseline visits up to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression of Severity (CGI-S) of depression rating [ Time Frame: at weeks 1, 2, 4, 6, 7, and 8, or last postbaseline observation ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning (GAF) Scale scores [ Time Frame: at weeks 4 and 8, or last postbaseline observation ] [ Designated as safety issue: No ]

Enrollment: 437
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Armodafinil 1
Armodafinil 150 mg/day
Drug: Armodafinil 1
Other Name: Nuvigil
Experimental: Armodafinil 2
Armodafinil 200 mg/day
Drug: Armodafinil 2
Other Name: Nuvigil
Placebo Comparator: 3
Placebo
Drug: Placebo
Matching Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has a diagnosis of bipolar I disorder according to DSM-IV-TR criteria and is currently experiencing a major depressive episode.
  • Documentation that the patient has had at least 1 previous manic or mixed episode.
  • The patient has had no more than 6 mood episodes in the last year.
  • The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.
  • The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, risperidone, or ziprasidone (only if taken in combination with lithium or valproic acid).
  • Written informed consent is obtained.
  • The patient is a man or woman 18 through 65 years of age.
  • 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.
  • 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.
  • The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
  • The patient has permanent accommodations and means of being contacted by the study center.
  • The patient understands that they may enroll in this clinical study only once and may not enroll in any other clinical study while participating in this trial.

Exclusion Criteria:

  • The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
  • The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
  • 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.
  • The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.
  • The patient has a history of alcohol or substance abuse or dependence (with the exception of nicotine dependence) within 3 months of the screening visit or during the screening period.
  • 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.
  • The patient has any clinically significant uncontrolled medical condition, treated or untreated.
  • The patient has received modafinil or armodafinil within the past 5 years, or the patient has a known sensitivity to any ingredients in the study drug tablets.
  • The patient has previously participated in a clinical study with armodafinil or has used any investigational product within 90 days of screening. The patient may not enroll in any other clinical study while participating in this study.
  • The patient has ever been treated with vagus nerve stimulation (VNS) or deep brain stimulation (DBS), or has been treated with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months of the screening visit.
  • The patient is a pregnant or lactating woman.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072929

  Show 40 Study Locations
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01072929     History of Changes
Other Study ID Numbers: C10953/3071
Study First Received: February 19, 2010
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014