Title
Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia
A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 40mg, 100mg, or 160mg as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
Phase
Phase 3Lead Sponsor
ShireStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
SchizophreniaIntervention/Treatment
lisdexamfetamine ...Study Participants
4The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).
Oral administration of 40 mg once-daily for up to 12 weeks
Oral administration of 100 mg once-daily for up to 12 weeks
Oral administration of 160 mg once-daily for up to 12 weeks
Oral administration once-daily for 12 weeks
Inclusion Criteria: 18 to 65 years of age Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject) Fixed home/place of residence and can be reached by telephone On a stable dose of antipsychotic medications Able to swallow capsules Exclusion Criteria: Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products Treated with clozapine in past 30 days Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions Uncontrolled hypertension History of thyroid disorder that has not been stabilized on thyroid medication Glaucoma Pregnant or nursing Subject has received an investigational product or participated in a clinical study within 30 day
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