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

Sponsored by:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00772005

Purpose

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

Condition	Intervention	Phase
Schizophrenia	Drug: armodafinil Drug: placebo	Phase II

MedlinePlus related topics: Schizophrenia

Drug Information available for: Armodafinil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	A 24-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (150, 200, and 250 mg/Day) as Adjunctive Therapy in Adults With Schizophrenia

Further study details as provided by Cephalon:

Primary Outcome Measures:

Positive and Negative Symptom Scale for Schizophrenia (PANSS) [ Time Frame: Week 24 (or last postbaseline observation). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PANSS [ Time Frame: Weeks 1,2,4,8,12,16,20,24 ] [ Designated as safety issue: Yes ]
Clinical Global Impression of Severity of Illness (CGI-S) [ Time Frame: Weeks 1,2,4,6,8,10,12,14,16,18,20,22, and 24 ] [ Designated as safety issue: No ]
Personal and Social Performance Scale (PSP) [ Time Frame: Weeks 4, 12, and 24 ] [ Designated as safety issue: No ]
CNSVitalSigns Cognitive Battery [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Clinical laboratory test results [ Time Frame: Weeks 4, 12, and 24 ] [ Designated as safety issue: Yes ]
Vital signs measurements [ Time Frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: Yes ]
ECG findings and physical examination findings [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Abnormal Involuntary Movement Scale (AIMS) scores [ Time Frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: Yes ]
Simpson-Angus EPS Scale scores [ Time Frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: Yes ]
Barnes Akathisia Rating Scale (BARS) scores [ Time Frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: Yes ]
Calgary Depression Scale for Schizophrenia (CDSS) scores [ Time Frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: Yes ]
Sleep Questionnaire [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	280
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 150 mg/day armodafinil	Drug: armodafinil 150 mg/day armodafinil
2: Active Comparator 200 mg/day armodafinil	Drug: armodafinil 200 mg/day armodafinil
3: Active Comparator 250 mg/day armodafinil	Drug: armodafinil 250 mg/day armodafinil
4: Placebo Comparator Matching Placebo	Drug: placebo placebo

Eligibility

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

Criteria

Key Inclusion Criteria:

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.
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.

Key Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772005

Contacts

Contact: Cephalon Contact

1-877-CEPHTRY

Show 24 Study Locations

Sponsors and Collaborators

Cephalon

Investigators

Study Director:

Sponsor's Medical Expert

Cephalon

More Information

Responsible Party:	Cephalon ( Sponsor's Medical Expert )
Study ID Numbers:	C10953/2034/SZ/MN
Study First Received:	October 10, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00772005
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Modafinil
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009