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

Purpose

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	Intervention	Phase
Schizophrenia	Drug: SPD489	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Lisdexamfetamine Lisdexamfetamine dimesylate

U.S. FDA Resources

Further study details as provided by Shire:

Primary Outcome Measures:

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks [ Time Frame: Basline and 52 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [ Time Frame: Baseline and week 52 ] [ Designated as safety issue: No ]
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]


Enrollment:	2
Study Start Date:	February 2013
Study Completion Date:	April 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

Not required

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760993

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


Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01760993 History of Changes
Other Study ID Numbers:	SPD489-336 2012-003920-18
Study First Received:	January 2, 2013
Results First Received:	May 1, 2014
Last Updated:	May 1, 2014
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016