Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: armodafinil; placebo; armodafinil; armodafinil
Intervention description: 150 mg/day armodafinil; placebo; 200 mg/day armodafinil; 250 mg/day armodafinil
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 287.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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
    

Eligibility 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.

          -  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.

        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.