Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

Shire

Status and phase

Terminated

Phase 3

Conditions

Schizophrenia

Treatments

Drug: SPD489

Study type

Interventional

Funder types

Industry

Identifiers

NCT01760993

2012-003920-18 (EudraCT Number)

SPD489-336

Details and patient eligibility

About

The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.

Full description

Not required

Enrollment

2 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 days