Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

Shire

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: SPD489 40mg; Drug: SPD489 100mg; Drug: Placebo; Drug: SPD489 160mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01738698

2012-003918-14 (EudraCT Number)

SPD489-338

Details and patient eligibility

About

The 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).

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 4 patient groups, including a placebo group

SPD489 40mg

Experimental group

Treatment:

Drug: SPD489 40mg

SPD489 100mg

Experimental group

Treatment:

Drug: SPD489 100mg

SPD489 160mg

Experimental group

Treatment:

Drug: SPD489 160mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo