Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits

NCT00487942 | Completed Phase 2 Results

• 1 other identifier: C10953/2033/SZ/US
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 12

Brief Summary

The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

  The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score.

  Baseline and 4 weeks (or last observation after Baseline)

Secondary Outcomes (78)

• Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score

  Baseline and 4 weeks

• Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

  Baseline 4 weeks (or last observation after baseline)

• Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

  Baseline and 4 weeks (or last observation after baseline)

• Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

  Baseline and 4 weeks (or last observation after Baseline)

• Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

  Baseline and 4 weeks (or last observation after Baseline)

Other Outcomes (15)

• Change From Baseline to Week 4 or Last Observation After Baseline in the Modified Simpson-Angus Scale Total Score

  Baseline and 4 weeks (or last observation after Baseline)

• Change From Baseline to Week 1 in the Modified Simpson-Angus Scale Total Score

  Baseline and 1 week following the start of study drug administration

• Change From Baseline to Week 2 in the Modified Simpson-Angus Scale Total Score

  Baseline and 2 weeks following the start of study drug administration

Study Arms (4)

50 mg/day armodafinil

ACTIVE COMPARATOR

Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 50 mg/day armodafinil treatment arm for the double-blind treatment period of the study took one 50 mg armodafinil tablet plus three placebo tablets each morning.

Drug: armodafinil

100 mg/day armodafinil

ACTIVE COMPARATOR

Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 100 mg/day armodafinil treatment arm for the double-blind treatment period of the study took two 50 mg armodafinil tablets plus two placebo tablets each morning. Subjects began taking 50 mg/day and then titrated to 100 mg/day on Day 2 of the first week of the double-blind treatment period.

Drug: armodafinil

200 mg/day armodafinil

ACTIVE COMPARATOR

Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 200 mg/day armodafinil treatment arm for the double-blind treatment period of the study took four 50 mg armodafinil tablet and no placebo tablets each morning. Subjects were titrated to this dose by starting treatment at 50 mg/day (1 tablet) and increasing by 50 mg increments on days 2, 4, and 6 until they were taking 200 mg/day.

Drug: armodafinil

Placebo

PLACEBO COMPARATOR

Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the placebo treatment arm for the double-blind treatment period of the study took four placebo tablets and no armodafinil tablets each morning.

Drug: placebo

Interventions

armodafinil DRUG

50 mg/day armodafinil

50 mg/day armodafinil

placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria as determined by the SCID and has been clinically stable in a nonacute phase of their illness for at least 8 weeks prior to the baseline visit.
• 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 olanzapine, oral risperidone, or paliperidone for at least 4 weeks prior to the screening visit. The patient is prepared to remain at these stable dosages for the duration of the study.
• The patient is a man or woman 18 through 60 years of age.
• The patient is in good health (except for the diagnosis of schizophrenia) 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 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 must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.

You may not qualify if:

• The patient has any Axis I disorder, including schizoaffective disorder and sleep disorders, apart from schizophrenia, and nicotine dependence.
• The patient has tardive dyskinesia or any other clinically significant movement disorder.
• The patient has any clinically significant uncontrolled medical (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition.
• The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
• The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)

Sponsors & Collaborators

• Cephalon: lead

Study Sites (12)

Collaborative NeuroScience Network

Garden Grove, California, 92845, United States

Location

Synergy Clinical Research

National City, California, 91950, United States

Location

California Clinical Trials

Paramount, California, 90723, United States

Location

CNRI-Los Angeles, LLC

Pico Rivera, California, 90660, United States

Location

CNRI-San Diego

San Diego, California, 92126, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Atlanta Center for Clinical Research

Atlanta, Georgia, 30308, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Duke Department of Psychiatry - DUMC

Durham, North Carolina, 27705, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45408, United States

Location

University Hills Clinical Research

Irving, Texas, 75062, United States

Location

Related Publications (1)

• Kane JM, D'Souza DC, Patkar AA, Youakim JM, Tiller JM, Yang R, Keefe RS. Armodafinil as adjunctive therapy in adults with cognitive deficits associated with schizophrenia: a 4-week, double-blind, placebo-controlled study. J Clin Psychiatry. 2010 Nov;71(11):1475-81. doi: 10.4088/JCP.09m05950gry. Epub 2010 Aug 24.

  PMID: 20816042 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Medical Monitor
• Organization: Cephalon, Inc.

1-800-896-5855

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 19, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 19, 2013
• Results First Posted: December 20, 2010

Record last verified: 2013-07

Locations

US (12)