Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Intervention: armodafinil; armodafinil; armodafinil; placebo
Intervention description: 50 mg/day armodafinil; 100 mg/day armodafinil; 200 mg/day armodafinil; placebo
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Key Inclusion Criteria:

          -  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.

        Key Exclusion Criteria:

          -  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.)