Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia

NCT00772005 | Completed Phase 2 Results DMC

• 1 other identifier: C10953/2034/SZ/MN
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 39

Brief Summary

The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint

  PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology.

  Baseline and Endpoint (Week 24 or last observation after baseline)

Secondary Outcomes (169)

• Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint

  Baseline and Endpoint (Week 24 or last observation after baseline)

• Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1

  Baseline and Week 1

• Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2

  Baseline and Week 2

• Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4

  Baseline and Week 4

• Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8

  Baseline and Week 8

Study Arms (4)

150 mg/day armodafinil

ACTIVE COMPARATOR

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.

Drug: armodafinil

200 mg/day armodafinil

ACTIVE COMPARATOR

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.

Drug: armodafinil

250 mg/day armodafinil

ACTIVE COMPARATOR

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.

Drug: armodafinil

Matching Placebo

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

armodafinil DRUG

150 mg/day armodafinil

Also known as: R-modafinil, CEP-10953

150 mg/day armodafinil

placebo DRUG

placebo

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria and the patient has been clinically stable in a nonacute phase of their illness.
• 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.

You may not qualify if:

• The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale.
• 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (39)

K and S Professional Research Services, LLC

Little Rock, Arkansas, 72201, United States

Location

Omega Clinical Trials

Anaheim, California, 92805, United States

Location

Synergy Clinical Research Center

Escondido, California, 92025, United States

Location

Collaborative NeuroScience

Garden Grove, California, 92845, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

CNRI Los Angeles LLC

Pico Rivera, California, 90660, United States

Location

CNRI-San Diego LLC

San Diego, California, 92116, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Collaborative NeuroScience Network

Torrance, California, 33613, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Scientific Clinical Research, Inc.

Aventura, Florida, 33180, United States

Location

Mental Health Advocates. Inc

Boca Raton, Florida, 33431, United States

Location

Fidelity Clinical Research

Lauderhill, Florida, 33319, United States

Location

Stedman Clinical Trials, LLC

Tampa, Florida, 33613, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Comprehensive Neuroscience Inc

Atlanta, Georgia, 30328, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Uptown Research Institute. LLC

Chicago, Illinois, 60640, United States

Location

Via Christi Research

Wichita, Kansas, 67214, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70601, United States

Location

Clinical Insights

Glen Burnie, Maryland, 21061, United States

Location

Sheppard Pratt Health System

Towson, Maryland, 21285, United States

Location

St Louis Clinical Trials LC

St Louis, Missouri, 63118, United States

Location

CRI Worldwide LLC

Clementon, New Jersey, 08021, United States

Location

Behavioral Medical Research of Brooklyn

Brooklyn, New York, 11201, United States

Location

Social Psychiatry Research Institute

Brooklyn, New York, 11235, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Behavioral Medical Research of Staten Island

Staten Island, New York, 10305, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45408, United States

Location

Keystone Clinical Studies LLC

Norristown, Pennsylvania, 19401, United States

Location

Belmont Center for Comprehensive Treatment

Philadelphia, Pennsylvania, 19131, United States

Location

CRI Worldwide

Philadelphia, Pennsylvania, 19139, United States

Location

Carolina Clinical Trials. Inc

Charleston, South Carolina, 29405, United States

Location

Community Clinical Research

Austin, Texas, 78754, United States

Location

FutureSearch Trials

Austin, Texas, 78756, United States

Location

University Hills Clinical Research

Irving, Texas, 75062, United States

Location

Alliance Research Group

Richmond, Virginia, 23230, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Related Publications (1)

• 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.

  PMID: 22178084 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: Vice President, Clinical Research, CNS/Pain
• Organization: Cephalon, Inc.

1-800-896-5855

Study Officials

• Sponsor's Medical Expert

  Cephalon

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 15, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 27, 2012
• Results First Posted: July 27, 2012

Record last verified: 2012-06

Locations

US (39)