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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: SPD489	Phase 3

Detailed Description:

Not required

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase 3, Long-term, Open-label, Multicenter, 52-week, Flexible-dose Safety Study of SPD489 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
Study Start Date :	February 2013
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	April 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: SPD489	Drug: SPD489; Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks; Other Name: lisdexamfetamine dimesylate, LDX, Vyvanse

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks [ Time Frame: Basline and 52 weeks ]
2. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
3. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 52 weeks ]
4. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
5. Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
6. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
7. Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
8. Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
9. Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]

Secondary Outcome Measures :

1. Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
2. Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
3. Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [ Time Frame: Baseline and week 52 ]
4. Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [ Time Frame: Up to 52 weeks ]
5. Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Oklahoma
SP Research PLLC/Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
CRI Lifetree
Philadelphia, Pennsylvania, United States, 19139

Sponsors and Collaborators

Shire

Investigators

Principal Investigator:	Stephen R. Marder, MD	Desert Pacific Mental Illness Research, Education, and Clinical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01760993 History of Changes
Other Study ID Numbers:	SPD489-336; 2012-003920-18 ( EudraCT Number )
First Posted:	January 4, 2013
Results First Posted:	May 29, 2014
Last Update Posted:	May 29, 2014
Last Verified:	May 2014

Keywords provided by Shire:

Not Required

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Antipsychotic Agents; Lisdexamfetamine Dimesylate; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs	Psychotropic Drugs; Central Nervous System Stimulants; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents