SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

Phase 3

Terminated

Interventions: Drug: SPD489 low dose range (40mg, 80mg, and 100mg)
Drug: SPD489 high dose range (120mg, 140mg and 160mg)
Drug: Placebo

Brief Summary: The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
SPD489 Low Dose Range	SPD489 low dose range (40mg, 80mg, and 100mg)	-
SPD489 High Dose Range	SPD489 high dose range (120mg, 140mg and 160mg)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks	Baseline and 26 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks	Baseline and 26 weeks
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks	Baseline and 26 weeks
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale	Baseline and week 26
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale	Up to 26 weeks
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks	Baseline and 26 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to 26 weeks
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks	Baseline and 26 weeks

Locations (4): Psychiatric Care and Research Center
🇺🇸
O'Fallon, Missouri, United States
CRI Lifetree
🇺🇸
Philadelphia, Pennsylvania, United States
Galiz Research
🇺🇸
Miami Springs, Florida, United States
St. Charles Psychiatric Associates
🇺🇸
Saint Charles, Missouri, United States