Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia
NCT ID: NCT00772005
Last Updated: 2012-07-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
287 participants
INTERVENTIONAL
2008-09-30
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
150 mg/day armodafinil
At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
armodafinil
150 mg/day armodafinil
200 mg/day armodafinil
At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
armodafinil
200 mg/day armodafinil
250 mg/day armodafinil
At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
armodafinil
250 mg/day armodafinil
Matching Placebo
At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
placebo
placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
armodafinil
150 mg/day armodafinil
placebo
placebo
armodafinil
200 mg/day armodafinil
armodafinil
250 mg/day armodafinil
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit.
* The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator.
* 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. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence.
* The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits.
Exclusion Criteria
* The patient has any Axis I disorder according to DSM-IV-TR criteria, including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study.
* The patient has moderate to severe depressive symptoms, as indicated by the CDSS.
* 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 tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder.
* The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies.
* The patient is a pregnant or lactating woman.
* The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cephalon
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sponsor's Medical Expert
Role: STUDY_DIRECTOR
Cephalon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
K and S Professional Research Services, LLC
Little Rock, Arkansas, United States
Omega Clinical Trials
Anaheim, California, United States
Synergy Clinical Research Center
Escondido, California, United States
Collaborative NeuroScience
Garden Grove, California, United States
Excell Research
Oceanside, California, United States
CNRI Los Angeles LLC
Pico Rivera, California, United States
CNRI-San Diego LLC
San Diego, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
Collaborative NeuroScience Network
Torrance, California, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Scientific Clinical Research, Inc.
Aventura, Florida, United States
Mental Health Advocates. Inc
Boca Raton, Florida, United States
Fidelity Clinical Research
Lauderhill, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Comprehensive Neuroscience Inc
Atlanta, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Uptown Research Institute. LLC
Chicago, Illinois, United States
Via Christi Research
Wichita, Kansas, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
Clinical Insights
Glen Burnie, Maryland, United States
Sheppard Pratt Health System
Towson, Maryland, United States
St Louis Clinical Trials LC
St Louis, Missouri, United States
CRI Worldwide LLC
Clementon, New Jersey, United States
Behavioral Medical Research of Brooklyn
Brooklyn, New York, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Behavioral Medical Research of Staten Island
Staten Island, New York, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Keystone Clinical Studies LLC
Norristown, Pennsylvania, United States
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
Carolina Clinical Trials. Inc
Charleston, South Carolina, United States
Community Clinical Research
Austin, Texas, United States
FutureSearch Trials
Austin, Texas, United States
University Hills Clinical Research
Irving, Texas, United States
Alliance Research Group
Richmond, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kane JM, Yang R, Youakim JM. Adjunctive armodafinil for negative symptoms in adults with schizophrenia: a double-blind, placebo-controlled study. Schizophr Res. 2012 Mar;135(1-3):116-22. doi: 10.1016/j.schres.2011.11.006. Epub 2011 Dec 16.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C10953/2034/SZ/MN
Identifier Type: -
Identifier Source: org_study_id